Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
Clinical Evaluation Systematic Literature Review - Apec-ahc.org
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Risk Analysis For The Intervention For<br />
Which The Subject Device Is Intended<br />
• Risks or complications associated with total knee replacement include,<br />
but are not limited to:<br />
• Early or late infection possibly necessitating the removal of the knee implant<br />
• Damage to nerves and blood vessels<br />
• Fracture of the bone surrounding the implant<br />
• Decrease in range of motion and/or mobility of the joint<br />
• Dislocation, fracture or loosening of the implant<br />
• Development of phlebitis, thrombosis, and/or pulmonary embolism<br />
• Possible revision surgery employing and alternative prosthesis or arthrodesis<br />
• Other complications like pain, deformity, decreased function of knee joint and<br />
need for transfusions or prolonged illness<br />
<strong>Clinical</strong> <strong>Evaluation</strong> Stage 1<br />
MEDDEV 2.7.1 Rev. 3, page 10<br />
20
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