It was reported that approximately 20 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, systemic metal related pathology symptoms, and localized metallosis.The patient reportedly had elevated cobalt and chromium levels attributing to lightheadedness, dizziness, loss of balance, tinnitus, visual changes, hearing changes, memory loss, brittle nails and teeth, and hair loss.During the revision, trunnion corrosion was identified.The femoral head was replaced with a dual mobility construct without complications, and the initial cup and stem were retained.No additional information.
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(b)(4).D10: cat# rd118850, lot# 881660, m2a 38mmx50mm cup.Cat# 11-173661, lot# 000350, m2a head.Product will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00260 and 0001825034-2024-00259.
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