(b)(4).Concomitant medical devices: 00801803203 versys head 60919187; 65771100700 stem 61418507; 00631004832 trilogy liner 61320625; 00625006535 bone screw 61436685.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02841, 0002648920 - 2020 - 00316.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: the patient had elevated metal ion levels.During the revision procedure, adverse local tissue reaction and scar tissue were identified.Black ring was observed on the trunnion.Anterior impingement at 45 degrees was noted during range of motion trials prior to dislocating the hip.The head and liner were replaced with new zimmer biomet products.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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It was reported patient underwent left hip revision approximately eight years post implantation due to elevated metal ions and altr.During the procedure, a pseudotumor was noted and excised, head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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