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The Power Of Simplicity At Work.<br />

Conquest Fx<br />

SURGICAL TECHNIQUE


TAPERED<br />

HIP SYSTEM<br />

SURGICAL TECHNIQUE COMPLETED<br />

IN CONJUNCTION WITH<br />

Pe<strong>te</strong>r Brooks, M.D.<br />

Cleveland, Ohio<br />

Wayne M. Golds<strong>te</strong>in, M.D.<br />

Chicago, Illinois<br />

Gia<strong>nn</strong>i L. Maistrelli, M.D., F.R.C.S.(C)<br />

Toronto, Ontario, Canada<br />

Nota Bene: The <strong>te</strong>chnique description herein is made available to the healthcare professional to illustra<strong>te</strong> the authors’ su<strong>gg</strong>es<strong>te</strong>d<br />

treatment for the un<strong>com</strong>plica<strong>te</strong>d procedure. In the final analysis, the prefe<strong>rr</strong>ed treatment is that which addresses the n<strong>ee</strong>ds of the patient.


2<br />

INTRODUCTION


The Conquest FX s<strong>te</strong>m is part of the<br />

Synergy Tapered Hip Sys<strong>te</strong>m, which<br />

<strong>com</strong>prises a variety of cementless and<br />

cemen<strong>te</strong>d s<strong>te</strong>ms to address different<br />

patient n<strong>ee</strong>ds. These include a highperformance<br />

cemen<strong>te</strong>d s<strong>te</strong>m, a porous<br />

cementless s<strong>te</strong>m, and hydroxyapati<strong>te</strong>coa<strong>te</strong>d<br />

cementless s<strong>te</strong>ms, all of which<br />

can be implan<strong>te</strong>d using the same basic<br />

instruments.<br />

The Conquest FX s<strong>te</strong>m is a cobalt<br />

chrome s<strong>te</strong>m that m<strong>ee</strong>ts the n<strong>ee</strong>ds of<br />

those patients who will benefit from an<br />

economi<strong>cal</strong>, low-demand hip s<strong>te</strong>m that<br />

takes advantage of the Synergy instrumentation.<br />

It is designed to be used in<br />

fracture or arthritis cases and may be<br />

implan<strong>te</strong>d with or without cement. S<strong>te</strong>m<br />

sizing is 9 mm to 16 mm, in 1 mm<br />

increments. It is available in standard<br />

offset only and uses the entire line of<br />

Smith & Nephew heads available in a<br />

12/14 taper, including both bipolar<br />

and unipolar replacements.<br />

<br />

3


STEM SPECIFICATIONS<br />

SPECIFICATIONS<br />

Coni<strong>cal</strong><br />

Neck Cross S<strong>te</strong>m A-P M-L<br />

Size Angle Section Length Width Width<br />

9 131° 9 mm 125 mm 13 mm 28 mm<br />

10 131° 10 mm 130 mm 14 mm 29 mm<br />

11 131° 11 mm 135 mm 15 mm 30 mm<br />

12 131° 12 mm 140 mm 16 mm 31 mm<br />

13 131° 13 mm 145 mm 17 mm 32 mm<br />

14 131° 14 mm 150 mm 18 mm 33 mm<br />

15 131° 15 mm 150 mm 19 mm 34 mm<br />

16 131° 16 mm 150 mm 21 mm 35 mm<br />

NECK HEIGHT MM<br />

When Femoral Head Component Selec<strong>te</strong>d Is:<br />

Size –3 +0 +4 +8 +12 +16<br />

9 26 28 30 33 35 38<br />

10 26 28 31 33 36 39<br />

11 27 29 32 34 37 39<br />

12 28 30 32 35 37 40<br />

13 28 30 33 35 38 41<br />

14 29 31 33 36 39 41<br />

15 30 32 34 37 39 42<br />

16 30 32 35 37 40 43<br />

NECK OFFSET MM<br />

When Femoral Head Component Selec<strong>te</strong>d Is:<br />

Size –3 +0 +4 +8 +12 +16<br />

9 32 34 37 40 43 46<br />

10 33 35 38 41 44 47<br />

11 34 36 39 42 45 48<br />

12 34 37 40 43 46 49<br />

13 35 37 40 43 46 49<br />

14 36 38 41 44 47 50<br />

15 37 39 42 45 48 51<br />

16 37 40 43 46 49 52<br />

NECK NECK LENGTH LENGTH MM MM<br />

When Femoral Head Component Selec<strong>te</strong>d Is:<br />

Size –3 +0 +4 +8 +12 +16<br />

9 27 30 34 38 42 46<br />

10 28 30 34 38 42 46<br />

11 28 31 35 39 43 47<br />

12 29 32 36 40 44 48<br />

13 30 32 36 40 44 48<br />

14 30 33 37 41 45 49<br />

15 31 34 38 42 46 50<br />

16 31 34 38 42 46 50<br />

The Conquest FX s<strong>te</strong>m is for use with Smith & Nephew 12/14 taper femoral heads only.<br />

4


OFFSET<br />

M-L WIDTH<br />

+16*<br />

+12*<br />

+ 8<br />

+ 4<br />

+ 0<br />

–3<br />

-3 and +16 CoCr<br />

femoral heads available<br />

in 28 mm and 32 mm<br />

O.D. only.<br />

*Deno<strong>te</strong>s skir<strong>te</strong>d heads<br />

NOTE: For illustration purposes<br />

only. Surgi<strong>cal</strong> <strong>te</strong>mpla<strong>te</strong>s are available<br />

by contacting your Smith<br />

& Nephew Representative or<br />

Customer Service.<br />

NOT ACTUAL SIZE<br />

STEM<br />

LENGTH<br />

0<br />

10<br />

20<br />

30<br />

NECK<br />

LENGTH<br />

CONICAL<br />

CROSS<br />

SECTION<br />

NECK HEIGHT<br />

A-P WIDTH<br />

<br />

5


PREOPERATIVE PLANNING<br />

Leg length de<strong>te</strong>rmination is difficult in fracture<br />

cases, particularly with a displaced fracture. The<br />

lack of skeletal continuity of<strong>te</strong>n prevents accura<strong>te</strong><br />

measurement. Other factors that can be assessed<br />

during surgery, such as joint stability and soft<br />

tissue <strong>te</strong>nsion, are re<strong>com</strong>mended. Each of these<br />

assessments helps in selecting the appropria<strong>te</strong><br />

trials during surgery.<br />

In elective procedures, leg length should be de<strong>te</strong>rmined<br />

before surgery. A tape measure may be used<br />

from the an<strong>te</strong>rior superior iliac spine to the medial<br />

malleolus to assess true leg length. Both of these<br />

landmarks offer a reliable bony prominence when<br />

approached from below. Al<strong>te</strong>rnatively, the A-P<br />

radiograph of the pelvis may be used to evalua<strong>te</strong> leg<br />

lengths. A straight edge is held tangential to the two<br />

obturator foramen or the ischial tuberosities, and<br />

the resulting line is marked where it in<strong>te</strong>rsects the<br />

femurs medially. Comparing where this line m<strong>ee</strong>ts<br />

the two femurs gives a measurement of leg length<br />

discrepancy, taking X-ray magnification into<br />

account (Figure 1).<br />

Conquest FX <strong>te</strong>mpla<strong>te</strong>s are used to select a s<strong>te</strong>m size<br />

and to predict the n<strong>ee</strong>ded head replacement for the<br />

required leg length. First, the acetabular <strong>com</strong>ponent,<br />

whether a fixed socket, bipolar or unipolar, is <strong>te</strong>mpla<strong>te</strong>d<br />

and the cen<strong>te</strong>r of rotation marked through<br />

the hole provided. The s<strong>te</strong>m <strong>te</strong>mpla<strong>te</strong> is chosen by<br />

overlaying successive sizes until a co<strong>rr</strong>ect size is<br />

found (Figure 2).<br />

The co<strong>rr</strong>ect size is one where the shoulder of the s<strong>te</strong>m<br />

is level with the junction of the grea<strong>te</strong>r trochan<strong>te</strong>r<br />

and the femoral neck, the s<strong>te</strong>m (or indica<strong>te</strong>d<br />

cement mantle, if desired) is snug in the shaft<br />

and there is good proximal fill. This usually results<br />

in a <strong>cal</strong>car os<strong>te</strong>otomy approxima<strong>te</strong>ly 1.5 cm or one<br />

finger breadth above the lesser trochan<strong>te</strong>r. Normal<br />

patient anatomy varies widely. Neck shaft angles<br />

and femoral neck lengths should be considered<br />

before the femoral head is resec<strong>te</strong>d.<br />

15<br />

+16<br />

+12<br />

+ 8<br />

+ 4<br />

+ 0<br />

–3<br />

*<br />

*<br />

For use with Smith &<br />

Nephew 12/14 femoral<br />

heads only.<br />

-3 and +16 CoCr<br />

femoral heads available<br />

in 28 mm and 32 mm<br />

O.D. only.<br />

*Deno<strong>te</strong>s skir<strong>te</strong>d heads<br />

150 mm<br />

39 mm<br />

0<br />

10<br />

20<br />

30<br />

C O N Q U E S T Fx S I Z E 1 5<br />

34 mm<br />

SIZE<br />

15<br />

120% MAGNIFNICATION<br />

32 mm<br />

0<br />

10<br />

20<br />

30<br />

40<br />

50<br />

60<br />

70<br />

80<br />

90<br />

100<br />

110<br />

120<br />

130<br />

140<br />

150<br />

MM<br />

160<br />

170<br />

180<br />

190<br />

200<br />

Re<strong>com</strong>mended<br />

Centralizer 13 mm<br />

210<br />

220<br />

Size 17 Broach Profile<br />

230<br />

©1999 Smith & Nephew, Inc., Memphis, TN U.S.A.<br />

Conquest Fx is a trademark of Smith & Nephew, Inc.<br />

Figure 2. An<strong>te</strong>ropos<strong>te</strong>rior radiograph<br />

demonstrating proper <strong>te</strong>mplating method.<br />

Figure 1. An<strong>te</strong>ropos<strong>te</strong>rior radiograph demonstrating one method<br />

of de<strong>te</strong>rmining leg length inequality.<br />

6


It is important to check that the s<strong>te</strong>m fits properly<br />

into the femur on the la<strong>te</strong>ral radiograph. It is<br />

the la<strong>te</strong>ral radiograph that shows best where<br />

thr<strong>ee</strong>-point fixation occurs.<br />

Once the appropria<strong>te</strong> s<strong>te</strong>m <strong>te</strong>mpla<strong>te</strong> is held at the<br />

co<strong>rr</strong>ect level, the range of neck lengths is assessed.<br />

The hole for any given neck length marks the cen<strong>te</strong>r<br />

of rotation for that head, and <strong>com</strong>paring this to the<br />

acetabular cen<strong>te</strong>r of rotation gives the change in<br />

offset and leg length that will be achieved af<strong>te</strong>r<br />

reduction. However, <strong>te</strong>mplating does not elimina<strong>te</strong><br />

the n<strong>ee</strong>d for careful trial reduction using first the<br />

broach and la<strong>te</strong>r, the implan<strong>te</strong>d s<strong>te</strong>m.<br />

A properly implan<strong>te</strong>d Conquest Fx s<strong>te</strong>m that provides<br />

both normal leg length and offset are shown in<br />

Figure 3. For this patient, the femoral implant<br />

was cemen<strong>te</strong>d in place.<br />

Figure 3. An<strong>te</strong>ropos<strong>te</strong>rior radiograph of<br />

a properly implan<strong>te</strong>d Conquest FX s<strong>te</strong>m<br />

used in cemen<strong>te</strong>d mode.<br />

<br />

7


1. Expose the Hip<br />

Position the patient and expose the hip joint in<br />

the desired ma<strong>nn</strong>er. Prior to dislocation, place<br />

a pin for measuring leg length in either the iliac<br />

crest or supra-acetabular bone. Make a small mark<br />

using cau<strong>te</strong>ry or ink on a convenient place on the<br />

femur, such as the vastus ridge. Measure and<br />

record the distance betw<strong>ee</strong>n these two points with<br />

a ruler or other device designed for this purpose.<br />

2. Femoral Os<strong>te</strong>otomy<br />

The level of the femoral neck<br />

os<strong>te</strong>otomy will have b<strong>ee</strong>n<br />

selec<strong>te</strong>d during preoperative<br />

<strong>te</strong>mplating. The angle of this<br />

os<strong>te</strong>otomy is de<strong>te</strong>rmined using the<br />

os<strong>te</strong>otomy guide, held parallel to the shaft<br />

of the femur. A line may be marked using<br />

the cau<strong>te</strong>ry tip.<br />

If the femoral shaft is held parallel to the<br />

floor and the femur is in<strong>te</strong>rnally rota<strong>te</strong>d<br />

an amount equal to the desired <strong>com</strong>ponent<br />

an<strong>te</strong>version, the saw may be<br />

poin<strong>te</strong>d straight down to achieve<br />

a properly an<strong>te</strong>ver<strong>te</strong>d cut without<br />

unwan<strong>te</strong>d flexion or ex<strong>te</strong>nsion<br />

(Figure 1).<br />

Figure 1<br />

8


3. Prepare<br />

Acetabulum<br />

If acetabular reconstruction is<br />

required, prepare the acetabulum<br />

according to the re<strong>com</strong>mended<br />

<strong>te</strong>chnique for the chosen implant.<br />

4. Femoral Canal<br />

Preparation<br />

The box os<strong>te</strong>otome is used<br />

first to remove remnants<br />

of the la<strong>te</strong>ral femoral<br />

neck (Figure 2). Using<br />

the T-handle, sound the<br />

canal with the tapered<br />

canal finder (Figure 3).<br />

NOTE: It is important to<br />

start la<strong>te</strong>rally to avoid varus<br />

positioning of the implants.<br />

Figure 2<br />

Figure 3<br />

<br />

9


5. Femoral Reaming<br />

Femoral reaming may be done using<br />

the T-handle or with power. Start<br />

la<strong>te</strong>rally to maintain alignment with<br />

the femoral shaft. Each reamer is<br />

marked with two or thr<strong>ee</strong> lines. Stop<br />

reaming when the line associa<strong>te</strong>d with<br />

the implant size that was <strong>te</strong>mpla<strong>te</strong>d<br />

reaches the medial <strong>cal</strong>car (Figure 4).<br />

NOTE: It is important to stay la<strong>te</strong>ral with the<br />

femoral reamers to help insure alignment<br />

with the femoral axis.<br />

Figure 4<br />

10


6. Broach Assembly/<br />

Disassembly<br />

Assemble the broach to the broach<br />

handle by placing the broach post<br />

in the clamp. Use thumb to lock the<br />

clamp onto the broach. A modular<br />

an<strong>te</strong>version handle can be assembled<br />

to the broach handle to provide<br />

version control (Figure 5).<br />

Disassemble the broach from the broach<br />

handle by placing two fingers (index<br />

and middle) into the rectangular slot.<br />

Apply pressure to the release bar by<br />

squ<strong>ee</strong>zing two fingers toward the<br />

thumb resting on the medial side of<br />

the broach handle frame (Figure 6).<br />

Figure 5<br />

Figure 6<br />

<br />

11


7. Femoral Broaching<br />

Begin with a broach that is at least<br />

two sizes smaller than the in<strong>te</strong>nded<br />

implant. K<strong>ee</strong>ping the desired an<strong>te</strong>version,<br />

broach progressively until the<br />

desired fit is achieved. Stop broaching<br />

when the top of the <strong>te</strong>mpla<strong>te</strong>d size<br />

broach coincides with the neck resection.<br />

It is important to start in the<br />

co<strong>rr</strong>ect la<strong>te</strong>ral position to maintain<br />

alignment with the shaft (Figure 7).<br />

Figure 7<br />

NOTE: For those surgeons who prefer<br />

a broach-only <strong>te</strong>chnique, full-cutting<br />

broaches are available.<br />

12


8. Calcar<br />

Preparation<br />

With the final broach fully<br />

sea<strong>te</strong>d, remove the broach<br />

handle and ream the <strong>cal</strong>car<br />

with either the small or large<br />

<strong>cal</strong>car reamer (Figure 8).<br />

Figure 8<br />

9. Trial Reduction<br />

Place the trial neck that<br />

matches the broach size onto<br />

the broach post. If a high offset<br />

is n<strong>ee</strong>ded, either the Synergy<br />

Porous, Synergy HA or Synergy<br />

Cemen<strong>te</strong>d s<strong>te</strong>m must be used.<br />

NOTE: Only standard offset<br />

is available in the Conquest FX.<br />

Do not use the high offset (HO)<br />

neck trial for trialing the<br />

Conquest FX s<strong>te</strong>m.<br />

Place the chosen head trial<br />

onto the neck trial (Figure 9).<br />

Reduce the hip and evalua<strong>te</strong><br />

in the following ways:<br />

Figure 9<br />

<br />

13


9. Trial Reduction (cont.)<br />

1. Soft tissue <strong>te</strong>nsion – some shuck is<br />

normal when applying a longitudinal<br />

distraction force to the hip. Shuck<br />

should not be excessive, and the hip<br />

should not disloca<strong>te</strong> (Figure 10).<br />

2. An<strong>te</strong>rior stability – place the leg<br />

in full adduction, full ex<strong>te</strong>nsion<br />

and hyperex<strong>te</strong>nsion, while exerting<br />

an ex<strong>te</strong>rnal rotation force. If the hip<br />

ca<strong>nn</strong>ot be fully ex<strong>te</strong>nded, it may<br />

be too tight. If it disloca<strong>te</strong>s easily,<br />

it is too loose and impingement<br />

must be addressed or <strong>com</strong>ponent<br />

malposition exists (Figure 11).<br />

3. Pos<strong>te</strong>rior stability – place the leg<br />

in neutral adduction and 90° flexion.<br />

Gradually rota<strong>te</strong> in<strong>te</strong>rnally. If it disloca<strong>te</strong>s<br />

with minimal in<strong>te</strong>rnal rotation,<br />

it is too loose and impingement must<br />

be addressed or <strong>com</strong>ponent malposition<br />

exists (Figure 12).<br />

Figure 10<br />

Figure 11<br />

Figure 12<br />

14


9. Trial Reduction (cont.)<br />

4. Sl<strong>ee</strong>p position – place the leg in the<br />

“sl<strong>ee</strong>p position” with the opera<strong>te</strong>d leg<br />

semiflexed, adduc<strong>te</strong>d and in<strong>te</strong>rnally<br />

rota<strong>te</strong>d over the other leg. Apply axial<br />

force to try to disloca<strong>te</strong>. This position<br />

represents a dangerous unstable position<br />

that may be adop<strong>te</strong>d by a patient<br />

sl<strong>ee</strong>ping on their nonopera<strong>te</strong>d side<br />

(Figure 13).<br />

5. Measure leg length – using the pin<br />

placed earlier in the iliac crest or<br />

supra-acetabular bone, remeasure the<br />

distance to the mark on the proximal<br />

femur. This indica<strong>te</strong>s the change in<br />

leg length with the selec<strong>te</strong>d neck trial.<br />

This is the last <strong>te</strong>st of the trial. Stability<br />

is <strong>te</strong>s<strong>te</strong>d first, because it is more important<br />

than leg length, which can be<br />

adjus<strong>te</strong>d by means of a shoe lift,<br />

if necessary, while postoperative<br />

instability of<strong>te</strong>n requires more<br />

invasive treatment.<br />

Figure 13<br />

<br />

15


10. S<strong>te</strong>m Insertion<br />

The Conquest FX s<strong>te</strong>m is designed<br />

so that it may be inser<strong>te</strong>d without<br />

cement. If this is desired, use the<br />

two-piece threaded driver to impact<br />

the chosen s<strong>te</strong>m into the prepared<br />

femur, using gentle mallet blows<br />

until fully sea<strong>te</strong>d. Ensure that it is<br />

stable. A line-to-line fit is achieved<br />

betw<strong>ee</strong>n the implant and bone when<br />

the implant that is chosen matches<br />

the last reamer and broach that<br />

are used (Figure 14).<br />

If cemen<strong>te</strong>d fixation is prefe<strong>rr</strong>ed,<br />

prepare the femoral canal by plu<strong>gg</strong>ing,<br />

brushing, cleaning with pulsatile<br />

lavage and drying with gauze sponges.<br />

Introduce the cement in its doughy<br />

phase using a cement gun in retrograde<br />

fashion, and pressurize the<br />

cement with a cement pressurizer.<br />

Selecting an implant two sizes smaller<br />

than the last broach will result in a<br />

minimum cement mantle of 1 mm<br />

all around, but with pressurization,<br />

much grea<strong>te</strong>r cement mantles are<br />

s<strong>ee</strong>n in practice. A cement centralizer<br />

of the appropria<strong>te</strong> size may be placed<br />

in the hole at the end of the s<strong>te</strong>m.<br />

The non-threaded driver is prefe<strong>rr</strong>ed<br />

for cemen<strong>te</strong>d fixation so that small<br />

hand movements are not transmit<strong>te</strong>d<br />

to the s<strong>te</strong>m during cement curing<br />

(Figure 15).<br />

NOTE: Regardless of the method of<br />

s<strong>te</strong>m fixation, a trial reduction should<br />

be performed with the implants.<br />

Cemen<strong>te</strong>d<br />

S<strong>te</strong>m Inser<strong>te</strong>r<br />

Figure 14<br />

Cementless<br />

S<strong>te</strong>m Inser<strong>te</strong>r<br />

Figure 15<br />

16


11. Final Trial<br />

Reduction<br />

A final trial reduction may<br />

be performed at this time<br />

using trial femoral heads<br />

(Figure 16).<br />

Figure 16<br />

12. Femoral Head<br />

Assembly<br />

Clean and dry the taper of the<br />

femoral <strong>com</strong>ponent. Impact the<br />

chosen head <strong>com</strong>ponent onto the<br />

femoral <strong>com</strong>ponent using a mallet<br />

and the femoral head impactor.<br />

Strike the femoral head impactor<br />

firmly with a mallet several times.<br />

The femoral head impactor should<br />

be held in line with the neck of<br />

the hip s<strong>te</strong>m (Figure 17).<br />

Expose and i<strong>rr</strong>iga<strong>te</strong> the<br />

acetabulum to ensure that<br />

no debris will be in<strong>te</strong>rposed<br />

in the joint. Carefully reduce<br />

the hip. Do a final check<br />

of soft tissue <strong>te</strong>nsion and<br />

leg length. Remove the<br />

leg length pin. Close<br />

in standard fashion.<br />

Figure 17<br />

<br />

17


CONQUEST FX FEMORAL STEM & HEAD COMPONENTS<br />

Porous-Coa<strong>te</strong>d Synergy S<strong>te</strong>ms<br />

Titanium 6Al-4V<br />

Standard High Offset<br />

Size Length Cat. No. Cat. No.<br />

9 135 mm 7130-6609 7130-6109<br />

10 140 mm 7130-6610 7130-6110<br />

11 145 mm 7130-6611 7130-6111<br />

12 150 mm 7130-6612 7130-6112<br />

13 155 mm 7130-6613 7130-6113<br />

14 160 mm 7130-6614 7130-6114<br />

15 165 mm 7130-6615 7130-6115<br />

16 170 mm 7130-6616 7130-6116<br />

17 175 mm 7130-6617 7130-6117<br />

18 180 mm 7130-6618 7130-6118<br />

Conquest Fx S<strong>te</strong>ms<br />

CoCr<br />

Size Length Cat. No.<br />

9 125 mm 7131-6509<br />

10 130 mm 7131-6510<br />

11 135 mm 7131-6511<br />

12 140 mm 7131-6512<br />

13 145 mm 7131-6513<br />

14 150 mm 7131-6514<br />

15 150 mm 7131-6515<br />

16 150 mm 7131-6516<br />

HA-Coa<strong>te</strong>d Synergy S<strong>te</strong>ms<br />

Titanium 6Al-4V<br />

Standard High Offset<br />

Size Length Cat. No. Cat. No.<br />

9 135 mm 7130-6709 7130-6409<br />

10 140 mm 7130-6710 7130-6410<br />

11 145 mm 7130-6711 7130-6411<br />

12 150 mm 7130-6712 7130-6412<br />

13 155 mm 7130-6713 7130-6413<br />

14 160 mm 7130-6714 7130-6414<br />

15 165 mm 7130-6715 7130-6415<br />

16 170 mm 7130-6716 7130-6416<br />

17 175 mm 7130-6717 7130-6417<br />

18 180 mm 7130-6718 7130-6418<br />

C A T A L O G I N F O R M A T I O N<br />

Titanium Press-Fit Synergy S<strong>te</strong>ms<br />

Titanium 6Al-4V<br />

Size Length Cat. No.<br />

9 135 mm 7130-6809<br />

10 140 mm 7130-6810<br />

11 145 mm 7130-6811<br />

12 150 mm 7130-6812<br />

13 155 mm 7130-6813<br />

14 160 mm 7130-6814<br />

15 165 mm 7130-6815<br />

16 170 mm 7130-6816<br />

17 175 mm 7130-6817<br />

18 180 mm 7130-6818<br />

Cemen<strong>te</strong>d Synergy S<strong>te</strong>ms<br />

Forged CoCr<br />

Standard High Offset<br />

Size Length Cat. No. Cat. No.<br />

9 110 mm 7131-6009 7131-6209<br />

10 115 mm 7131-6010 7131-6210<br />

11 120 mm 7131-6011 7131-6211<br />

12 125 mm 7131-6012 7131-6212<br />

13 130 mm 7131-6013 7131-6213<br />

14 135 mm 7131-6014 7131-6214<br />

15 140 mm 7131-6015 7131-6215<br />

19


CONQUEST FX FEMORAL STEM & HEAD COMPONENTS<br />

Zirconia 12/14 Taper<br />

Femoral Heads<br />

Neck<br />

Length 22 mm 26 mm 28 mm<br />

+0 — 7132-0026 7132-0028<br />

+4 7132-0422 7132-0426 7132-0428<br />

+8 7132-0822 7132-0826 7132-0828<br />

CoCr 12/14 Femoral Heads<br />

Cobalt Chromium – ASTM F 799<br />

Neck<br />

Length 22 mm 26 mm 28 mm 32 mm<br />

–3 — — 7130-2803 7130-3203<br />

+0 7130-2200 7130-2600 7130-2800 7130-3200<br />

+4 7130-2204 7130-2604 7130-2804 7130-3204<br />

+8 7130-2208 7130-2608 7130-2808 7130-3208<br />

+12 7130-2212 7130-2612 7130-2812 7130-3212<br />

+16 — — 7130-2816 7130-3216<br />

Invis Distal Centralizers<br />

Cat. No. O.D. Cat. No. O.D.<br />

7131-3208 8 mm 7131-3215 15 mm<br />

7131-3209 9 mm 7131-3216 16 mm<br />

7131-3210 10 mm 7131-3217 17 mm<br />

7131-3211 11 mm 7131-3218 18 mm<br />

7131-3212 12 mm 7131-3219 19 mm<br />

7131-3213 13 mm 7131-3220 20 mm<br />

7131-3214 14 mm 7131-3221 21 mm<br />

20


CONQUEST FX<br />

Femoral Instrumentation Tray No. 1<br />

Cat. No. 7136-6201<br />

Os<strong>te</strong>otomy Guide<br />

Cat. No. 7136-4000<br />

Box Os<strong>te</strong>otome<br />

Cat. No. Size<br />

7136-4002 Small<br />

7136-4003 Large<br />

Canal Finder<br />

Cat. No. 7136-4001<br />

INSTRUMENTATION<br />

Tapered Reamer<br />

Cat. No. Size<br />

7136-6209 8-9-10<br />

7136-6211 11-12<br />

7136-6213 13-14<br />

7136-6215 15-16<br />

7136-6217 17-18<br />

Broach Handle<br />

(Two Per Set)<br />

Cat. No. 7136-4007<br />

C A T A L O G I N F O R M A T I O N<br />

T-Handle<br />

Cat. No. 7136-4006<br />

An<strong>te</strong>version Handle<br />

Cat. No. 7136-4012<br />

21


CONQUEST FX<br />

INSTRUMENTATION<br />

Femoral Instrumentation Tray No. 2<br />

Cat. No. 7136-6202<br />

Tapered Broach<br />

Cat. No. Size Cat. No. Size<br />

7136-6308 8 7136-6314 14<br />

7136-6309 9 7136-6315 15<br />

7136-6310 10 7136-6316 16<br />

7136-6311 11 7136-6317 17<br />

7136-6312 12 7136-6318 18<br />

7136-6313 13<br />

Trial Neck, Standard<br />

Cat. No. Size<br />

7136-6408 8-13<br />

7136-6414 14-18<br />

Trial Neck, High Offset<br />

Cat. No. Size<br />

7136-6508 8-13<br />

7136-6514 14-18<br />

Fully Toothed Broach<br />

Cat. No. Size Cat. No. Size<br />

7136-6708 8 7136-6714 14<br />

7136-6709 9 7136-6715 15<br />

7136-6710 10 7136-6716 16<br />

7136-6711 11 7136-6717 17<br />

7136-6712 12 7136-6718 18<br />

7136-6713 13<br />

Calcar Reamer<br />

Cat. No. Size<br />

7136-4004 Small<br />

7136-4005 Large<br />

22


S<strong>te</strong>m Inser<strong>te</strong>r<br />

Frame<br />

Cat. No. 7136-4008<br />

Cemen<strong>te</strong>d S<strong>te</strong>m<br />

Inser<strong>te</strong>r<br />

Cat. No. 7136-4014<br />

CONQUEST FX<br />

INSTRUMENTATION<br />

Trial 12/14 Taper Femoral Heads<br />

Neck Color 22 mm 26 mm 32 mm<br />

Length Code Optional Optional 28 mm Optional<br />

–3 Gr<strong>ee</strong>n — — 7135-2803 7135-3203<br />

+0 Yellow 7135-2200 7135-2600 7135-2800 7135-3200<br />

+4 Red 7135-2204 7135-2604 7135-2804 7135-3204<br />

+8 Whi<strong>te</strong> 7135-2208 7135-2608 7135-2808 7135-3208<br />

+12 Blue 7135-2212 7135-2612 7135-2812 7135-3212<br />

+16 Black — — 7135-2816 7135-3216<br />

Femoral Head<br />

Impactor<br />

Cat. No. 7136-4009<br />

Slap Hammer Weight<br />

Cat. No. 7136-4010<br />

C A T A L O G I N F O R M A T I O N<br />

S<strong>te</strong>m Inser<strong>te</strong>r<br />

Pommel<br />

Cat. No. 7136-4011<br />

23


IMPORTANT NOTE<br />

Total hip replacement arthroplasty has be<strong>com</strong>e a successful procedure<br />

for relieving pain and restoring motion in patients who are disabled<br />

from hip arthropathy. The goals of total hip replacement are to<br />

decrease pain, increase function, and increase mobility.<br />

MATERIALS<br />

The Total Hip Sys<strong>te</strong>m is manufactured from ma<strong>te</strong>rials as outlined<br />

below. The <strong>com</strong>ponent ma<strong>te</strong>rial is provided on the outside carton label.<br />

Component Ma<strong>te</strong>rial Ma<strong>te</strong>rial Standards<br />

Femoral Components Ti-6Al-4V ASTM F 136 and ISO 5832/3 or<br />

or ASTM F 1472 and ISO 5832/3<br />

Co-Cr-Mo or<br />

ASTM F 799 and ISO 5832/12<br />

or<br />

ASTM F 75 and ISO 5832/4<br />

Acetabular shells Ti-6Al-4V ASTM F 1472 and ISO 5832/3<br />

Proximal pads<br />

Taper sl<strong>ee</strong>ves<br />

Distal sl<strong>ee</strong>ves<br />

Fixation screws and pegs<br />

Hole covers<br />

Acetabular <strong>com</strong>ponents UHMWPE ASTM F 648<br />

Acetabular liners<br />

Femoral centralizers PMMA Not applicable<br />

Acetabular spacer pods<br />

X-ray marking wire Co-Cr-Mo ASTM F 90 and ISO 5832/5<br />

Acetabular Reconstruction CP Titanium ASTM F 67 and ISO 5832/2<br />

Ring<br />

Acetabular<br />

Reinforcement Ring<br />

Femoral Heads Co-Cr-Mo ASTM F 799 and ISO 5832/12<br />

Zirconia ISO 13356<br />

Ceramic<br />

Porous titanium <strong>com</strong>ponents and porous Co-Cr-Mo <strong>com</strong>ponents are<br />

coa<strong>te</strong>d with <strong>com</strong>mercially pure (C.P.) titanium beads (ASTM F 67 and<br />

ISO 5832/2) and Co-Cr-Mo beads (ASTM F 75), respectively.<br />

Hydroxylapati<strong>te</strong> coatings include HA (ASTM F 1185) that is applied<br />

either on a grit blas<strong>te</strong>d or porous surface. NOTE: HA coa<strong>te</strong>d porous<br />

implants are not available in the USA.<br />

Zirconia ceramic femoral heads are yttria stabilized zirconia ceramic.<br />

Some of the alloys n<strong>ee</strong>ded to produce orthopedic implants contain<br />

some metallic <strong>com</strong>ponents that may be carcinogenic in tissue cultures<br />

or intact organism under very unique circumstances. Questions have<br />

b<strong>ee</strong>n raised in the scientific li<strong>te</strong>rature as to whether or not these alloys<br />

may be carcinogenic in implant recipients. Studies conduc<strong>te</strong>d to evalua<strong>te</strong><br />

this issue have not identified conclusive evidence of such phenomenon,<br />

in spi<strong>te</strong> of the millions of implants in use.<br />

DESCRIPTION OF SYSTEM<br />

The Total Hip Sys<strong>te</strong>m consists of femoral <strong>com</strong>ponents, proximal<br />

pads, taper sl<strong>ee</strong>ves, distal sl<strong>ee</strong>ves, acetabular <strong>com</strong>ponents, fixation<br />

screws and pegs, hole covers, centralizers, and femoral heads.<br />

Components may be grit blas<strong>te</strong>d, porous coa<strong>te</strong>d, hydroxylapati<strong>te</strong><br />

(HA) coa<strong>te</strong>d, or HA porous coa<strong>te</strong>d. All implantable devices are<br />

designed for single use only.<br />

Femoral Components<br />

Femoral <strong>com</strong>ponents are available in a variety of sizes. Porous coa<strong>te</strong>d<br />

<strong>com</strong>ponents are coa<strong>te</strong>d for biologi<strong>cal</strong> ingrowth. Proximally and distally<br />

modular femoral <strong>com</strong>ponents accept proximal pads and distal sl<strong>ee</strong>ves,<br />

respectively. Non-porous femoral <strong>com</strong>ponents can feature PMMA centralizers<br />

that help produce a uniform thickness of cement in a concentric<br />

ma<strong>nn</strong>er.<br />

Femoral <strong>com</strong>ponents are available with a small, large (14/16), or<br />

12/14 global taper (gage diame<strong>te</strong>rs 0.404, 0.564, and 0.500 inches,<br />

respectively).<br />

Small taper femoral <strong>com</strong>ponents ma<strong>te</strong> and lock directly with a 22 mm<br />

metal or ceramic head. The small taper also ma<strong>te</strong>s with a taper<br />

sl<strong>ee</strong>ve which, in turn, ma<strong>te</strong>s with either metal or ceramic heads (26,<br />

28, or 32 mm), bipolar or unipolar <strong>com</strong>ponents.<br />

Large taper femoral <strong>com</strong>ponents ma<strong>te</strong> and lock with either metal heads<br />

(26, 28, or 32 mm), ceramic heads (22, 28 or 32 mm), bipolar or unipolar<br />

<strong>com</strong>ponents.<br />

Femoral <strong>com</strong>ponents with a 12/14 taper ma<strong>te</strong> and lock with either<br />

metal heads (22, 26, 28, or 32 mm), ceramic heads (26 or 28 mm),<br />

bipolar or unipolar <strong>com</strong>ponents.<br />

Small, large, and 12/14 taper femoral <strong>com</strong>ponent tapers are<br />

machined to ma<strong>te</strong> and lock with ceramic heads, thus preventing rotation<br />

of the ceramic head on the s<strong>te</strong>m, the lat<strong>te</strong>r would cause wear of<br />

the s<strong>te</strong>m taper.<br />

IMPORTANT MEDICAL INFORMATION<br />

Warnings and Precautions<br />

Total Hip Sys<strong>te</strong>m<br />

Taper Sl<strong>ee</strong>ves<br />

A taper sl<strong>ee</strong>ve is required to be impac<strong>te</strong>d on the small taper femoral<br />

<strong>com</strong>ponent prior to impacting a femoral head size 26, 28, or 32 mm. A<br />

taper sl<strong>ee</strong>ve is required to attach a unipolar head. Unipolar taper<br />

sl<strong>ee</strong>ves are available in small, large, and 12/14 tapers. Never place<br />

more than one taper sl<strong>ee</strong>ve on a femoral <strong>com</strong>ponent.<br />

Femoral Heads<br />

Cobalt chromium (22, 26, 28, and 32 mm) and ceramic (22, 26, 28, and<br />

32 mm) heads are available in multiple neck lengths for proper<br />

anatomic and musculature fit. Heads are highly polished for reduced<br />

friction and wear. The following zirconia ceramic heads are available<br />

for use only with small (0.404) and large (.564) taper femoral <strong>com</strong>ponents.<br />

Zirconia<br />

Head<br />

Ceramic Diame<strong>te</strong>r Neck Length<br />

42-7815 32 mm Standard 0 mm<br />

42-7816 32 mm Long 4 mm<br />

42-7817 32 mm X-Long 8 mm<br />

42-7818 28 mm Standard 0 mm<br />

42-7819 28 mm Long 4 mm<br />

42-7820 28 mm X-Long 8 mm<br />

No<strong>te</strong>: 32 mm heads with a -3 mm neck length are not available for use<br />

with the small taper s<strong>te</strong>ms.<br />

In addition to the <strong>com</strong>ponents lis<strong>te</strong>d above, the following <strong>com</strong>ponents<br />

are available for use only with small (0.404) taper femoral <strong>com</strong>ponents<br />

Zirconia<br />

Head<br />

Ceramic Diame<strong>te</strong>r Neck Length<br />

7132-0002 22 mm Long 4 mm<br />

7132-0006 22 mm X-Long 8 mm<br />

No<strong>te</strong>: 22 mm Zirconia Ceramic Heads used with small (0.404) taper<br />

femoral <strong>com</strong>ponents are not available in the USA.<br />

The following zirconia ceramic heads are available for use only with<br />

12/14 taper femoral <strong>com</strong>ponents:<br />

Zirconia<br />

Head<br />

Ceramic Diame<strong>te</strong>r Neck Length<br />

7132-0028 28 mm Standard 0 mm<br />

7132-0428 28 mm Long 4 mm<br />

7132-0828 28 mm X-Long 8 mm<br />

7132-0026 26 mm Standard 0 mm<br />

7132-0426 26 mm Long 4 mm<br />

7132-0826 26 mm X-Long 8 mm<br />

7132-0422 22 mm Long 4 mm<br />

7132-0822 22 mm X-Long 8 mm<br />

Acetabular Components<br />

Acetabular <strong>com</strong>ponents can be one piece all polyethylene or twopiece<br />

<strong>com</strong>ponents consisting of a titanium shell and a polyethylene<br />

liner. Please s<strong>ee</strong> Warnings and Precautions for specific information<br />

on screws, pegs and hole covers use. Acetabular reinforcement and<br />

reconstruction rings are used with an all polyethylene acetabular<br />

<strong>com</strong>ponent.<br />

Femoral <strong>com</strong>ponents and femoral heads are designed for use with any<br />

Smith & Nephew polyethylene acetabular <strong>com</strong>ponent or polyethylenelined,<br />

metal-backed acetabular <strong>com</strong>ponent having an appropria<strong>te</strong>lysized<br />

inside diame<strong>te</strong>r.<br />

INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS<br />

Hip <strong>com</strong>ponents are indica<strong>te</strong>d for individuals undergoing primary and<br />

revision surgery where other treatments or devices have failed in rehabilitating<br />

hips damaged as a result of trauma or noninflammatory<br />

degenerative joint disease (NIDJD) or any of its <strong>com</strong>posi<strong>te</strong> diagnoses<br />

of os<strong>te</strong>oarthritis, avascular necrosis, traumatic arthritis, slipped capital<br />

epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.<br />

Hip <strong>com</strong>ponents are also indica<strong>te</strong>d for inflammatory degenerative joint<br />

disease including rheumatoid arthritis, arthritis secondary to a variety<br />

of diseases and anomalies, and congenital dysplasia; old, remo<strong>te</strong><br />

os<strong>te</strong>omyelitis with an ex<strong>te</strong>nded drainage-fr<strong>ee</strong> period, in which case, the<br />

patient should be warned of an above normal danger of infection postoperatively;<br />

treatments of nonunion, femoral neck fracture and<br />

trochan<strong>te</strong>ric fractures of the proximal femur with heads involvement<br />

that are unmanageable using other <strong>te</strong>chniques; endoprosthesis,<br />

femoral os<strong>te</strong>otomy, or Girdlestone resection; fracture-dislocation of the<br />

hip; and co<strong>rr</strong>ection of deformity.<br />

Acetabular reinforcement and reconstruction rings are in<strong>te</strong>nded to be<br />

used in primary and revision surgeries where the acetabulum has the<br />

deficiencies of the acetabular roof, an<strong>te</strong>rior or pos<strong>te</strong>rior pillar, medial<br />

wall deficiency, and / or protrusion as a result of the indications lis<strong>te</strong>d<br />

previously.<br />

Some of the diagnoses lis<strong>te</strong>d above and below may also increase the<br />

chance of <strong>com</strong>plications and reduce the chance of a satisfactory result.<br />

Contraindications<br />

1. Conditions that would elimina<strong>te</strong> or <strong>te</strong>nd to elimina<strong>te</strong> adequa<strong>te</strong><br />

implant support or prevent the use of an appropria<strong>te</strong>ly-sized<br />

implant, e.g.:<br />

a. blood supply limitations;<br />

b. insufficient quantity or quality of bone support, e.g., os<strong>te</strong>oporosis,<br />

or metabolic disorders which may impair bone formation,<br />

and os<strong>te</strong>omalacia; and<br />

c. infections or other conditions which lead to increased bone<br />

resorption.<br />

2. Mental or neurologi<strong>cal</strong> conditions which <strong>te</strong>nd to impair the patient's<br />

ability or willingness to restrict activities.<br />

3. Physi<strong>cal</strong> conditions or activities which <strong>te</strong>nd to place extreme loads<br />

on implants, e.g., Charcot joints, muscle deficiencies, multiple joint<br />

disabilities, etc.<br />

4. Skeletal immaturity.<br />

5. The zirconia ceramic head is contraindica<strong>te</strong>d for use with any other<br />

product than an UHMW polyethylene cup or a metal backed<br />

UHMW polyethylene cup.<br />

Contraindications may be relative or absolu<strong>te</strong> and must be carefully<br />

weigh<strong>te</strong>d against the patient's entire evaluation and the prognosis for<br />

possible al<strong>te</strong>rnative procedures such as non-operative treatment,<br />

arthrodesis, femoral os<strong>te</strong>otomy, pelvic os<strong>te</strong>otomy, resection arthroplasty,<br />

hemiarthroplasty and others.<br />

Conditions presenting increased risk of failure include: os<strong>te</strong>oporosis,<br />

metabolic disorders which may impair bone formation, and<br />

os<strong>te</strong>omalacia.<br />

Possible Adverse Effects<br />

1. Wear of the polyethylene articulating surfaces of acetabular <strong>com</strong>ponents<br />

has b<strong>ee</strong>n repor<strong>te</strong>d following total hip replacement. Higher<br />

ra<strong>te</strong>s of wear may be initia<strong>te</strong>d by the presence of particles of<br />

cement, metal, or other debris which can develop during or as a<br />

result of the surgi<strong>cal</strong> procedure and cause abrasion of the articulating<br />

surfaces. Higher ra<strong>te</strong>s of wear may shor<strong>te</strong>n the useful life of<br />

the prosthesis, and lead to early revision surgery to replace the<br />

worn prosthetic <strong>com</strong>ponents.<br />

2. With all joint replacements, asymptomatic, lo<strong>cal</strong>ized, progressive<br />

bone resorption (os<strong>te</strong>olysis) may occur around the prosthetic <strong>com</strong>ponents<br />

as a consequence of foreign-body reaction to particula<strong>te</strong><br />

wear debris. Particles are genera<strong>te</strong>d by in<strong>te</strong>raction betw<strong>ee</strong>n <strong>com</strong>ponents,<br />

as well as betw<strong>ee</strong>n the <strong>com</strong>ponents and bone, primarily<br />

through wear mechanisms of adhesion, abrasion, and fatigue.<br />

Secondarily, particles may also be genera<strong>te</strong>d by third-body particles<br />

lodged in the polyethylene articular surface. Os<strong>te</strong>olysis can<br />

lead to future <strong>com</strong>plications necessitating the removal or replacement<br />

of prosthetic <strong>com</strong>ponents.<br />

3. Loosening, bending, cracking, or fracture of implant <strong>com</strong>ponents<br />

may result from failure to observe the Warnings and Precautions<br />

below. Fracture of the implant can occur as a result of trauma,<br />

strenuous activity, improper alignment, or duration of service.<br />

4. Dislocations, subluxation, decreased range of motion, or lengthening<br />

or shor<strong>te</strong>ning of the femur caused by improper neck selection,<br />

positioning, looseness of acetabular or femoral <strong>com</strong>ponents, extraneous<br />

bone, penetration of the femoral prosthesis through the shaft<br />

of the femur, fracture of the acetabulum, intrapelvic protrusion of<br />

acetabular <strong>com</strong>ponent, femoral impingement, periarticular <strong>cal</strong>cification,<br />

and/or excessive reaming.<br />

5. Fracture of the pelvis or femur: post-operative pelvic fractures are<br />

usually stress fractures. Femoral fractures are of<strong>te</strong>n caused by<br />

defects in the femoral cor<strong>te</strong>x due to misdirec<strong>te</strong>d reaming, etc.<br />

Intraoperative fractures are usually associa<strong>te</strong>d with old congenital<br />

deformity, improper s<strong>te</strong>m selection, improper broaching, and/or<br />

severe os<strong>te</strong>oporosis.<br />

6. Infection, both acu<strong>te</strong> post-operative wound infection and la<strong>te</strong> d<strong>ee</strong>p<br />

wound sepsis.<br />

7. Neuropathies; femoral, sciatic, peroneal nerve, and la<strong>te</strong>ral femoral<br />

cutaneous neuropathies have b<strong>ee</strong>n repor<strong>te</strong>d. Temporary or permanent<br />

nerve damage resulting in pain or numbness of the affec<strong>te</strong>d limb.<br />

8. Wound hematoma, thromboembolic disease including venous<br />

thrombosis, pulmonary embolus, or myocardial infarction.<br />

9. Myositis ossificans, especially in males with hypertrophic arthritis,<br />

limi<strong>te</strong>d pre-operative range of motion and/or previous myositis.<br />

Also, periarticular <strong>cal</strong>cification with or without impediment to joint<br />

mobility can cause decreased range of motion.<br />

10. Trochan<strong>te</strong>ric nonunion usually associa<strong>te</strong>d with early weight bearing<br />

and/or improper fixation of the trochan<strong>te</strong>r, when a transtrochan<strong>te</strong>ric<br />

surgi<strong>cal</strong> approach is used.<br />

11. Although rare, metal sensitivity reactions and/or allergic reactions<br />

to foreign ma<strong>te</strong>rials have b<strong>ee</strong>n repor<strong>te</strong>d in patients following joint<br />

replacement.<br />

12. Damage to blood vessels.<br />

13. Traumatic arthrosis of the kn<strong>ee</strong> from intraoperative positioning of<br />

the extremity.<br />

14. Delayed wound healing.<br />

15. A<strong>gg</strong>rava<strong>te</strong>d problems of the affec<strong>te</strong>d limb or contrala<strong>te</strong>ral extremity<br />

caused by leg length discrepancy, excess femoral medialization, or<br />

muscle deficiency.<br />

24


16. Failure of the porous coating/ substra<strong>te</strong> in<strong>te</strong>rface or hydroxylapati<strong>te</strong><br />

coating/ porous coating bonding may result in bead separation<br />

delamination.<br />

17. S<strong>te</strong>m migration or subsidence has occu<strong>rr</strong>ed in conjunction with<br />

<strong>com</strong>paction grafting procedures usually resulting from insufficient<br />

graft ma<strong>te</strong>rial or improper cement <strong>te</strong>chniques. Varus s<strong>te</strong>m alignment<br />

may also be responsible.<br />

WARNINGS AND PRECAUTIONS<br />

The patient should be warned of surgi<strong>cal</strong> risks, and made aware of<br />

possible adverse effects. The patient should be warned that the device<br />

does not replace normal healthy bone, that the implant can break or<br />

be<strong>com</strong>e damaged as a result of strenuous activity or trauma, and that<br />

it has a fini<strong>te</strong> expec<strong>te</strong>d service life and may n<strong>ee</strong>d to be replaced in the<br />

future. Do not mix <strong>com</strong>ponents from different manufacturers. Additional<br />

Warnings and Precautions may be included in <strong>com</strong>ponent li<strong>te</strong>rature.<br />

Preoperative<br />

1. Use extreme care in handling and storage of implant <strong>com</strong>ponents.<br />

Cutting, bending, or scratching the surface of <strong>com</strong>ponents can significantly<br />

reduce the strength, fatigue resistance, and/or wear charac<strong>te</strong>ristics<br />

of the implant sys<strong>te</strong>m. These, in turn, may induce<br />

in<strong>te</strong>rnal stresses that are not obvious to the eye and may lead to<br />

fracture of the <strong>com</strong>ponent. Implants and instruments should be pro<strong>te</strong>c<strong>te</strong>d<br />

from co<strong>rr</strong>osive environments such as salt air during storage.<br />

Do not allow the porous surfaces to <strong>com</strong>e in contact with cloth or<br />

other fiber-releasing ma<strong>te</strong>rials.<br />

2. Allergies and other reactions to device ma<strong>te</strong>rials, although infrequent,<br />

should be considered, <strong>te</strong>s<strong>te</strong>d for (if appropria<strong>te</strong>), and ruled<br />

out preoperatively.<br />

3. Fixation and expec<strong>te</strong>d longevity of <strong>com</strong>ponents expec<strong>te</strong>d to be left<br />

in place at revision surgery should be thoroughly assessed.<br />

4. Surgi<strong>cal</strong> <strong>te</strong>chnique information is available upon request. The surgeon<br />

should be familiar with the <strong>te</strong>chnique.<br />

5. Intraoperative fracture or breaking of instruments can occur.<br />

Instruments which have experienced ex<strong>te</strong>nsive use or excessive<br />

force are susceptible to fracture. Instruments should be examined<br />

for wear, or damage, prior to surgery.<br />

6. Do not cold wa<strong>te</strong>r quench ceramic <strong>com</strong>ponents and never s<strong>te</strong>rilize<br />

ceramic heads while fixed on the s<strong>te</strong>m taper. (S<strong>ee</strong> s<strong>te</strong>rilization section,<br />

below.)<br />

7. Select <strong>com</strong>ponents such that the Zirconia ceramic head always<br />

articula<strong>te</strong>s with a UHMW polyethylene cup or a metal backed<br />

UHMW polyethylene cup. Zirconia ceramic should never articula<strong>te</strong><br />

against metal because severe wear of the metal will occur.<br />

8. Select only Smith & Nephew femoral <strong>com</strong>ponents that indica<strong>te</strong><br />

their use with ceramic heads. This is important because the taper<br />

on the s<strong>te</strong>m is machined to tightly ma<strong>te</strong> and lock with the ceramic<br />

head thus preventing rotation of the ceramic head on the s<strong>te</strong>m.<br />

Also, an improperly dimensioned taper could result in fracture of<br />

the ceramic head.<br />

9. The zirconia ceramic head is <strong>com</strong>posed of a new ceramic ma<strong>te</strong>rial<br />

with limi<strong>te</strong>d clini<strong>cal</strong> history. Although mechani<strong>cal</strong> <strong>te</strong>sting demonstra<strong>te</strong>s<br />

that when used with a polyethylene acetabular <strong>com</strong>ponent,<br />

the yttria stabilized zirconia ball produces a relatively low amount<br />

of particula<strong>te</strong>s, the total amount of particula<strong>te</strong> remains unde<strong>te</strong>rmined.<br />

Because of the limi<strong>te</strong>d clini<strong>cal</strong> and preclini<strong>cal</strong> experience,<br />

the biologi<strong>cal</strong> effect of these particula<strong>te</strong>s can not be predic<strong>te</strong>d.<br />

Intraoperative<br />

1. The general principles of patient selection and sound surgi<strong>cal</strong> judgment<br />

apply. The co<strong>rr</strong>ect selection of the implant is extremely important.<br />

The appropria<strong>te</strong> type and size should be selec<strong>te</strong>d for patients<br />

with consideration of anatomi<strong>cal</strong> and biomechani<strong>cal</strong> factors such<br />

as patient age and activity levels, weight, bone and muscle conditions,<br />

any prior surgery and anticipa<strong>te</strong>d future surgeries, etc.<br />

Generally, the largest cross-section <strong>com</strong>ponent which will allow<br />

adequa<strong>te</strong> bone support to be maintained is prefe<strong>rr</strong>ed. Failure to<br />

use the optimum-sized <strong>com</strong>ponent may result in loosening, bending,<br />

cracking, or fracture of the <strong>com</strong>ponent and/or bone.<br />

2. Co<strong>rr</strong>ect selection of the neck length and cup, and s<strong>te</strong>m positioning,<br />

are important. Muscle looseness and/or malpositioning of<br />

<strong>com</strong>ponents may result in loosening, subluxation, dislocation,<br />

and/or fracture of <strong>com</strong>ponents. Increased neck length and varus<br />

positioning will increase stresses which must be borne by the<br />

s<strong>te</strong>m. The <strong>com</strong>ponent should be firmly sea<strong>te</strong>d with the <strong>com</strong>ponent<br />

insertion instruments.<br />

3. Care should be taken not to scratch, bend (with the exception of<br />

the Reconstruction Rings) or cut metal <strong>com</strong>ponents during surgery<br />

for the reasons sta<strong>te</strong>d in Number One of the "Preoperative" section<br />

of "Warnings and Precautions."<br />

4. A +12 mm or +16 mm femoral head should not be used with<br />

any small taper s<strong>te</strong>ms.<br />

5. Distal sl<strong>ee</strong>ves should not be used to bridge corti<strong>cal</strong> defects<br />

that lie within 25 mm of the tip of the base s<strong>te</strong>m.<br />

6. Matrix small taper s<strong>te</strong>m sizes 8S–10L must have a minimum neck<br />

length of +8 mm when used with a bipolar <strong>com</strong>ponent; and small<br />

taper s<strong>te</strong>m sizes 12S–16L must have a minimum neck length of<br />

+4 mm when used with a bipolar <strong>com</strong>ponent.<br />

7. Modular heads and femoral <strong>com</strong>ponents should be from the same<br />

manufacturer to prevent mismatch of tapers.<br />

8. Clean and dry s<strong>te</strong>m taper prior to impacting the femoral head or<br />

taper sl<strong>ee</strong>ve. The modular femoral head <strong>com</strong>ponent must be firmly<br />

sea<strong>te</strong>d on the femoral <strong>com</strong>ponent to prevent disassociation.<br />

9. Take care, when positioning and drilling screw and peg holes, to<br />

avoid penetration of the i<strong>nn</strong>er cor<strong>te</strong>x of the pelvis, penetration of the<br />

sciatic notch, or damage to vital neurovascular structures.<br />

Perforation of the pelvis with screws that are too long can rupture<br />

blood vessels causing the patient to hemo<strong>rr</strong>age. Do not place a<br />

screw in the cen<strong>te</strong>r hole of the acetabular prosthesis.<br />

Placement of drills and screws in the an<strong>te</strong>rior or medial portions of<br />

the prosthesis is associa<strong>te</strong>d with a high risk of po<strong>te</strong>ntially fatal vascular<br />

injury.<br />

Bone screws must be <strong>com</strong>ple<strong>te</strong>ly sea<strong>te</strong>d in the holes of the shell to<br />

allow proper locking for the acetabular <strong>com</strong>ponent liner. If the<br />

tapered pegs n<strong>ee</strong>d to be removed from the shell af<strong>te</strong>r impaction of<br />

the pegs, do not reuse the pegs or the peg shell holes. Use new<br />

pegs and different shell holes, or a new shell if necessary.<br />

10. USE ONLY REFLECTION ® TITANIUM BONE SCREWS, UNIVER-<br />

SAL CANCELLOUS BONE SCREWS, TAPERED PEGS, AND<br />

HOLE COVERS with the Reflection Acetabular Component and<br />

USE ONLY OPTI-FIX ® TITANIUM BONE SCREWS AND UNIVER-<br />

SAL CANCELLOUS BONE SCREWS with the Opti-Fix Acetabular<br />

Component. The Reflection In<strong>te</strong>rfit and the Reflection For Screws<br />

Only (FSO) shells accept Universal Cancellous, Reflection screws,<br />

and tapered screw-hole covers, not pegs. Tapered pegs can only<br />

be used with Reflection V Shells. The threaded cen<strong>te</strong>r hole in<br />

Reflection Shells only accepts the threaded hole cover, not screws<br />

or pegs. The In<strong>te</strong>rFit threaded hole cover is only for use with<br />

Reflection In<strong>te</strong>rfit. The Reflection threaded hole cover can be used<br />

with both Reflection and In<strong>te</strong>rFit shells. Refer to product li<strong>te</strong>rature<br />

for proper adjunctive fixation and hole cover usage.<br />

11. Prior to seating modular <strong>com</strong>ponents, surgi<strong>cal</strong> debris including tissue<br />

must be cleaned from the surfaces. Debris, including bone<br />

cement, may inhibit the <strong>com</strong>ponent locking mechanism. If the shell<br />

is to be cemen<strong>te</strong>d in place, remove extraneous cement with a plastic<br />

sculps tool to ensure proper locking of the liner. During liner<br />

insertion, make sure soft tissue does not in<strong>te</strong>rfere with the<br />

shell/liner in<strong>te</strong>rface. Chilling the liner reduces the impaction force<br />

required to seat the liner. Modular <strong>com</strong>ponents must be assembled<br />

securely to prevent disassociation. Debris inhibits the proper fit and<br />

locking of modular <strong>com</strong>ponents which may lead to early failure of<br />

the procedure. Failure to properly seat the acetabular liner into the<br />

shell can lead to disassociation of the liner from the shell.<br />

12. Avoid repea<strong>te</strong>d assembly and disassembly of the modular <strong>com</strong>ponents<br />

which could <strong>com</strong>promise the criti<strong>cal</strong> locking action of the<br />

locking mechanism.<br />

13. Care is to be taken to assure <strong>com</strong>ple<strong>te</strong> support of all parts of the<br />

device embedded in bone cement to prevent stress concentration<br />

which may lead to failure of the procedure. During curing of the<br />

cement, care should be taken to prevent movement of the implant<br />

<strong>com</strong>ponents.<br />

14. If <strong>com</strong>ponents are to be left in place at revision surgery, they should<br />

first be thoroughly checked for signs of looseness, etc. and<br />

replaced if necessary. The head/neck <strong>com</strong>ponent should be<br />

changed only when clini<strong>cal</strong>ly necessary.<br />

15. Once removed from the patient, implants previously implan<strong>te</strong>d<br />

should never be reused, since in<strong>te</strong>rnal stresses which are not visible<br />

may lead to early bending or fracture of these <strong>com</strong>ponents.<br />

16. With the congenitally disloca<strong>te</strong>d hip, special care should be taken<br />

to prevent sciatic nerve palsy. Also, no<strong>te</strong> that the femoral canal is<br />

of<strong>te</strong>n very small and straight and may require an extra-small<br />

straight femoral prosthesis; however, a regular-sized prosthesis<br />

should be used when possible. No<strong>te</strong> that the true acetabulum is<br />

rudimentary and shallow. A false acetabulum should not ordinarily<br />

be utilized as a cup placement si<strong>te</strong> for anatomi<strong>cal</strong> and biomechani<strong>cal</strong><br />

reasons.<br />

17. With rheumatoid arthritis, especially for those patients on s<strong>te</strong>roids,<br />

bone may be extremely os<strong>te</strong>oporotic. Care should be taken to prevent<br />

excessive penetration of the acetabular floor or fracture of the<br />

medial acetabular wall, femur, or grea<strong>te</strong>r trochan<strong>te</strong>r.<br />

18. Revision procedures for previous arthroplasty, Girdlestone, etc.,<br />

are <strong>te</strong>chni<strong>cal</strong>ly demanding and difficult to exercise. Common<br />

e<strong>rr</strong>ors include misplacement of the incision, inadequa<strong>te</strong> exposure<br />

or mobilization of the femur, inadequa<strong>te</strong> removal of ectopic bone,<br />

or improper positioning of <strong>com</strong>ponents. Postoperative instability<br />

as well as excessive blood loss can result. In summary, increased<br />

operative time, blood loss, increased incidence of pulmonary<br />

embolus and wound hematoma can be expec<strong>te</strong>d with revision<br />

procedures.<br />

19. Prior to closure, the surgi<strong>cal</strong> si<strong>te</strong> should be thoroughly cleaned of<br />

cement, bone chips, ectopic bone, etc. Ectopic bone and/or bone<br />

spurs may lead to dislocation or painful or restric<strong>te</strong>d motion.<br />

Range of motion should be thoroughly checked for early contact<br />

or instability.<br />

Postoperative<br />

1. Postoperative directions and warnings to patients by physicians,<br />

and patient care, are extremely important. Gradual weight bearing<br />

is begun af<strong>te</strong>r surgery in ordinary total hip arthroplasty. However,<br />

with trochan<strong>te</strong>r os<strong>te</strong>otomy or certain <strong>com</strong>plex cases, weight-bearing<br />

status should be individualized with the non or partial weightbearing<br />

period ex<strong>te</strong>nded.<br />

2. Patients should be warned against unassis<strong>te</strong>d activity, particularly<br />

use of toilet facilities and other activities requiring excessive motion<br />

of the hip.<br />

3. Use extreme care in patient handling. Support should be provided<br />

to the operative leg when moving the patient. While placing the<br />

patient on bedpans, changing dressings, and clothing, and similar<br />

activities, precautions should be taken to avoid placing excessive<br />

load on the operative part of the body.<br />

4. Postoperative therapy should be structured to regain muscle<br />

strength around the hip and a gradual increase of activities.<br />

5. Periodic x-rays are re<strong>com</strong>mended for close <strong>com</strong>parison with immedia<strong>te</strong><br />

postoperative conditions to de<strong>te</strong>ct long-<strong>te</strong>rm evidence of<br />

changes in position, loosening, bending and/or cracking of <strong>com</strong>ponents<br />

or bone loss. With evidence of these conditions, patients<br />

should be closely observed, the possibilities of further de<strong>te</strong>rioration<br />

evalua<strong>te</strong>d, and the benefits of early revision considered.<br />

6. Prophylactic antibiotics should be re<strong>com</strong>mended to the patient similar<br />

to those su<strong>gg</strong>es<strong>te</strong>d by the American Heart Association for conditions<br />

or situations that may result in bac<strong>te</strong>remia.<br />

PACKAGING AND LABELING<br />

Components should only be accep<strong>te</strong>d if received by the hospital or surgeon<br />

with the factory packaging and labeling intact.<br />

STERILIZATION/RESTERILIZATION<br />

Most implants are supplied s<strong>te</strong>rile and have b<strong>ee</strong>n packaged in pro<strong>te</strong>ctive<br />

trays. The method of s<strong>te</strong>rilization is no<strong>te</strong>d on the package label. All<br />

radiation s<strong>te</strong>rilized <strong>com</strong>ponents have b<strong>ee</strong>n exposed to a minimum of<br />

25 kilo Grays of gamma radiation. If not specifi<strong>cal</strong>ly labeled s<strong>te</strong>rile, the<br />

implants and instruments are supplied non-s<strong>te</strong>rile and must be s<strong>te</strong>rilized<br />

prior to use. Inspect packages for punctures or other damage prior<br />

to surgery.<br />

Metal Components<br />

Nonporous metal <strong>com</strong>ponents may be initially s<strong>te</strong>rilized or res<strong>te</strong>rilized,<br />

if necessary, by s<strong>te</strong>am autoclaving in appropria<strong>te</strong> pro<strong>te</strong>ctive wrapping,<br />

af<strong>te</strong>r removal of all original packaging and labeling. Pro<strong>te</strong>ct the<br />

devices, particularly mating surfaces, from contact with metal or other<br />

hard objects which could damage the product. The following process<br />

parame<strong>te</strong>rs are re<strong>com</strong>mended for these devices:<br />

• Prevac<strong>uu</strong>m Cycle: 4 pulses (Maximum = 26.0 psig [2.8 bars] &<br />

Minimum = 10.0 inHg [339 millibars]) with a minimum dwell time of 4<br />

minu<strong>te</strong>s at 270°F to 275°F (132°C to 135°C), followed by a 1 minu<strong>te</strong><br />

purge and at least 15 minu<strong>te</strong>s of vac<strong>uu</strong>m drying at 10 inHg (339 millibars)<br />

minimum.<br />

• Gravity Cycle: 270°F to 275°F (132°C to 135°C) with a minimum<br />

dwell time at <strong>te</strong>mperature of 15 minu<strong>te</strong>s, followed by a 1 minu<strong>te</strong><br />

purge and at least 15 minu<strong>te</strong>s of vac<strong>uu</strong>m drying at 10 inHg (339 millibars)<br />

minimum.<br />

Smith & Nephew does not re<strong>com</strong>mend the use of low <strong>te</strong>mperature<br />

gravity cycles or flash s<strong>te</strong>rilization on implants.<br />

Do not res<strong>te</strong>rilize femoral prostheses with ceramic heads sea<strong>te</strong>d on<br />

the s<strong>te</strong>m.<br />

If porous coa<strong>te</strong>d implants are inadver<strong>te</strong>ntly contamina<strong>te</strong>d, return the<br />

unsoiled prosthesis to Smith & Nephew for res<strong>te</strong>rilization. DO NOT<br />

RESTERILIZE porous coa<strong>te</strong>d implants. The porous coating requires<br />

special cleaning procedures.<br />

Plastic Components<br />

Plastic <strong>com</strong>ponents may be res<strong>te</strong>rilized by ethylene oxide gas. The following<br />

parame<strong>te</strong>rs are re<strong>com</strong>mended as starting points for cycle validation<br />

by the health care facility:<br />

S<strong>te</strong>rilant Temp. Humidity Maximum Concen- Exposure<br />

Pressure tration Time<br />

10% EtO 130˚F 40-60% 28 PSIA 550-650 120<br />

90% HCFC (55˚C) (1930 millibar) mg/L minu<strong>te</strong>s<br />

10% EtO 100˚F 40-60% 28 PSIA 550-650 6<br />

90% HCFC (38˚C) (1930 millibar) mg/L hours<br />

100% EtO 131˚F 30-60% 10 PSIA 736 30<br />

(55˚C) (689 millibar) mg/L minu<strong>te</strong>s<br />

Su<strong>gg</strong>es<strong>te</strong>d initial starting point for aeration validation is 12 hours at<br />

122˚F (50˚C) with power aeration. Consult aerator manufacturer for<br />

more specific instructions.<br />

Ceramic Components<br />

Do not res<strong>te</strong>rilize ceramic femoral heads.<br />

INFORMATION<br />

For further information, please contact Customer Service at (800) 238-<br />

7538 for <strong>cal</strong>ls within the continental USA and (901) 396-2121 for all<br />

in<strong>te</strong>rnational <strong>cal</strong>ls.<br />

Caution: Federal Law (USA) restricts this device to sale by or on<br />

the order of a physician.<br />

3433198 Rev. 0 10/98<br />

25


Smith & Nephew, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.<br />

(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1-800-238-7538<br />

Conquest FX, Synergy, the Synergy design, Matrix, Opti-Fix, and Reflection are trademarks of Smith & Nephew, Inc. ©1999 Smith & Nephew, Inc. 4/99 7138-0438

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