It was reported that approximately 14 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, and elevated metal ion levels.During the revision surgery, metal related pathology, joint effusion, and osteolysis were noted.The cup and head components were exchanged.There were no surgical complications.No additional information is available.
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(b)(4).D10: cat# us157856 lot# 010080 m2a-magnum pf cup 56odx50id.Cat# x11-180317 lot# 817370 bi-metric/x por nc lat 17x165.Cat# 157450 lot# 189170 m2a-magnum mod hd sz 50mm.Product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034-2024-00567.0001825034-2024-00568.0001825034-2024-00569.
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