The associated complaint devices were not returned.A clinical evaluation was conducted and details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.No cardiac markers or labs have been submitted either.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported stiffness and myocardial infarction cannot be determined.Root cause of the arthrofibrosis could be contributed to concomitant medical problems, rehabilitation, and history (bilateral hip replacement, bilateral knee meniscus repair, bilateral knee osteoarthritis, hypertension, mi) patient impact: 1) arthrofibrosis and mua 2) myocardial infarction treated with bypass and stent placement procedure with a hospital stay both incidents are listed as having been resolved.No further medical assessment is warranted based on the information provided.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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