(b)(4).D10: cat# x11-180317 lot# 891560 bi-metric/x por nc lat 17x165.Cat# 157452 lot# 595220 m2a-magnum mod hd sz 52mm.Cat# 139264 lot # 058290 m2a-magnum 52-60mm tpr insrt-6.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: 0001825034-2024-00563, 0001825034-2024-00565, 0001825034-2024-00566.
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It was reported that approximately 14 years post implantation of a right total hip arthroplasty, the patient was revised due to pain, and elevated metal ion levels.During the revision surgery, metal related pathology, joint effusion, inflammation, 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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