(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# us157858 lot# 192930 m2a-magnum pf cup 58odx52id.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: 0001825034-2024-00561 0001825034-2024-00563 0001825034-2024-00565.
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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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