(b)(4).Concomitant medical products: item# 00875705601/ shell / lot #63122316.Item# 00875101236/ liner/ lot # 63032799.Item# 00771101000/ stem/ lot # 63175924.Item# 00625006530/ screw/ lot #62845852.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.Initial op notes demonstrated that the patient had left tha due to osteoarthritis.Revision op notes demonstrated that the patient was revised due to pain and loosening.The previous cup was grossly loose.No difficulty removing the screws and cup.There was minimal loss of bone only at the screw holes and a posterior cyst but no compromise of the columns.Abductor tear chronic.New cup, screws, liner, and head were implanted.Complaint confirmed with op notes provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00661, 0002648920-2020-00095.
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