Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
• Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
• Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
• Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
• Willing to voluntarily sign the informed consent form
• Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.