It was reported patient underwent a left partial knee arthroplasty on (b)(6), 2004.Subsequently, the patient was revised on (b)(6), 2014 due to patella/femoral arthrosis and anterior impingement.All components were removed and replaced with a total knee system.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".
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