(b)(4).D10: cat# 15-105004, lot# 017870, m2a-taper liner sz 41/32.Cat# 11-163669, lot# 328100, 32mm m2a mod head std nk.Cat# 103800, lot# 410280, tprlc reg por fmrl 7.5x135.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: 0001825034-2024-00373, 0001825034-2024-00371, and 0001825034-2024-00374.
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It was reported that approximately 23 years post implantation of a right total hip arthroplasty, the patient was revised due to asymptomatic presentation of elevated metal ion levels.During the revision, trunnionosis was identified upon removal of the femoral head from the stem.The acetabular component was well-fixed but was revised to allow for additional anteversion.The initial stem was retained.No additional information.
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