(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00231 and 0001825034-2020-00232.Concomitant medical products: mod arthro 7 deg lck collar, catalog#: cp260602, lot#: 968130.Mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 161950.Oss porous im stem 21.5 x 150, catalog#: 150400, lot#: 360910.Oss porous im stem 18.5 x 225, catalog#: 150405, lot#: 898500.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that during a revision of a left knee oss system due to a broken junction/connector component, the surgeon stated that the morris taper could not be broken from the femoral stem despite multiple attempts and different instruments.The surgery had to be modified to cut the segments apart, extending surgical time by an hour.
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Multiple mdr reports were filed for this event, associated reports: 0001825034-2020-00231 and 0001825034-2020-02071.This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and the returned device.Medical records were provided and reviewed by a healthcare professional.Review found the stem was well fixed in the patient.The surgeon tried to remove the already fractured diaphyseal connector from the stem but couldn¿t and was noted as an intraop complication that delayed the surgery.Visual examination of the returned product found the connector fractured and intentionally cut on the portion that connects to the stem.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.
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