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 1 of 10 for (b)(4).
|
Additional product codes: hrs and hwc.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.
|