It was reported that approximately 16 years post implantation of a left total hip arthroplasty, the patient was revised for concern of metallosis development and pain.During the revision, it was reported that the femoral head was extremely hard to remove as it was cold welded to the trunnion.A substantial amount of scar tissue was also removed from the hip joint.There were no surgical complications.No additional information was available.
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(b)(4).D10: cat# 139254 lot# 708230 m2a-magnum 42-50mm tpr insrt-3 0/-3mmt1.Cat# 157446 lot# 823450 m2a-magnum mod hd sz 46mm.Cat# 103206 lot# 731470 taperloc por fmrl 12.5x145.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: 0001825034-2024-00857, 0001825034-2024-00859.
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