(b)(4).Concomitant medical product: unknown orthopedic salvage system axle, catalog#: 161035 lot#: 159990.Unknown orthopedic salvage system bearing, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system femoral, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system tibial tray, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system stem, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system femoral bushing, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system tibial bushing, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system yoke, catalog#: unknown lot#: unknown.Unknown orthopedic salvage system pin, catalog#: unknown lot#: unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-11060, 0001825034-2018-00246, 0001825034-2018-00247, 0001825034-2018-00248.
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It was reported that the patient underwent revision surgery due to unknown reasons.The bearing, assembly, and diaphyseal segment were removed and replaced.It was noted by the surgeon that the axle had a scratch in the portion that makes contact with the yoke.The surgeon further noted that there were no product issues and that the patient¿s tissue was colored black around the prosthesis.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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