(b)(4).Concomitant medical products: catalog number:65771100920, lot number: 60707596, brand name: m/l taper stem.Catalog number:00801803202, lot number:61047644, brand name: trilogy cups.Catalog number:00630505032, lot number: 61034302, brand name: xlpe liner.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00488.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient underwent a revision procedure due to metallosis and pseudotumor.Patient had elevated metal ions and mri imaging demonstrated large fluid collection.There was tissue destruction inside of the hip secondary to pseudotumor.The trochanter was bald with no abductor muscles attached anymore.There was corrosion on the trunnion and taper of the femoral head.The locking ring was bent and the new locking ring did not engage properly.The shell, liner, and head were removed.The patient tolerated the procedure well.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.
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It was reported that the patient was revised due to metallosis approximately 8 years post implantation.During the revision, the locking ring was bent and the new locking ring did not engage properly.The shell, liner, and head were removed.Attempts have been made and additional information on the reported event is unavailable.
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