(b)(4).D10: unknown m2a magnum cup, unknown magnum modular head.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00897.0001825034 - 2024 - 00898.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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It was reported that the patient underwent a revision procedure 14 years and 10 months post implantation due to pain and elevated metal ion levels.Altr, osteolysis, and cold welding were also confirmed during the procedure.The head and cup were exchanged without any known complications.There is no additional information available at the time of this report.
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