(b)(4).D10: cat# us157856, lot# 086360, m2a-magnum pf cup 56odx50id.Cat# 157450, lot# 709400, m2a-magnum mod hd sz 50mm.Cat# 192412, lot# 536270, echo por fmrl red nc 12x140mm.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: 0001825034-2024-00860, 0001825034-2024-00861, and 0001825034-2024-00862.
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It was reported that approximately 9 years post implantation of a right total hip arthroplasty, the patient was revised for concern of metallosis development, elevated metal ion levels, and pain.The patient was noted to have a 7mm discrepancy between limbs.During the revision of the femoral head and limb lengthening procedure, scar tissue and synovial inflammation were also noted.There were no reported complications.No additional information was available.
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