(b)(4).Foreign report source: (b)(6).It is unknown at this time if the device will be returned for evaluation as the location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00315.
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It was reported the patient underwent a revision procedure of the right hip approximately 9 years post implantation due to pain, pseudotumor, dislocation, metallosis, implant wear, difficulty ambulating, tissue damage, swelling.Attempts have been made and additional information on the reported event is unavailable at this time.
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The following sections were updated/corrected updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 the event was confirmed with medical records received.Review of the medical records identified the following: patient underwent an initial right total hip arthroscopy due to coxarthrosis with subchondral sclerosis, reduced joint spacing, and osteophytosis.No intraoperative complications were noted.-patient experienced dislocation approximately 9 years later.Patient reported pain and swelling.A ct scan confirmed pseudotumor.-ongoing complications from the initial implant include residual lumbago, coxalgia, stenotic deficit, and discrete ambulatory dysfunction.-patient was revised due to metal related pathology.Extensive damage to external rotators, dense fibrous tissue around pseudotumor.Brown liquid drained from pseudocapsule.Stem stable and well osseointegrated, left in place.Acetabular component removed without complication, bone graft placed in the acetabular bed.Pathology report confirmed reactive fibrosis with diffuse macrophage reaction and focal metallosis.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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