It was reported a patient had a revision surgery for a distal femur non-union and the hardware was broken so it was removed.The hardware included a 4.5mm variable angle locking compression plate, 5.0mm variable angle locking screws and 5.0mm dynamic locking screws.The hardware was removed and washed out.The wound was then closed.After reviewing intraoperative x-rays, it was decided that a total knee replacement would be best for this patient.The patient will be seen by total joint specialist to have the knee replaced at a future date.No surgical delay was reported.This is report 3 of 10 for (b)(4).
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Date of event: unknown.Additional product codes: hrs and hwc.Implant date: unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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