(b)(4).Concomitant medical products: catalog number: 00620005420, lot number: 61260606, brand name: acetabular shell; catalog number: 00625006540, lot number: 60897278, brand name: bone screw; catalog number: 00625006520, lot number: 61070811, brand name: bone screw; catalog number:00625006525, lot number: 61319981, brand name: bone screw; catalog number: 00801803202, lot number: 61111779, brand name: cocr head; catalog number: 00784101250, lot number:60121561, brand name: versys stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-02374, 0002648920-2019-00503, 0002648920-2019-00504.The patient underwent a revision procedure due to failed right total hip arthroplasty secondary to metallosis and trunnionosis.Patient had elevated metal ions with cobal level around 3 and chromium level about 1.1.A pseudocapsule with dark serosanguineous fluid was observed.The hip was very stiff.There was soft tissue damage with necrosis in the synovium, and bone loss in the posterolateral regions of acetabulum.There was some wear on the trunnion with a small black rim of debris at the base of trunnion indicating corrosion.The liner was discolored and exhibited wear.The head and liner were removed.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies 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.Device not returned for evaluation.
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