(b)(4).Concomitant medical devices: 15-105056-m2a 1 pc shell 38mmx56mm-831000; 11-173666-m2a 38mm mod hd +12mm nk skrt-140670; 14-103202-taperloc microp fmrl 7.5mm-374630.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00398 - 1, 0001825034 - 2020 - 00399 - 1, 0001825034 - 2020 - 01925.Reported event was confirmed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp).Dx: painful left tha, probable metallosis, broken fixation screw.Workup for infection negative, crp <5.0, metal ions elevated, mri showed fluid collection with an overall appearance of metallosis.Large amount of dark sanguineous fluid present, moderate metal staining in the synovial tissues and bone surface of the acetabulum, rim screw broken, scant if any osseous integration on the back of the acetabulum, femoral component well fixed.Modest to moderate wear on the trunnion and metallic debris within the femoral head suggested that trunnionosis was indeed the likely cause of metal debris.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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