(b)(4).Concomitant medical products: bearing 28 mm i.D.46 mm o.D.Size g , item# 110031001 , lot# 64515040; cer bioloxd option hd 28mm , item# 650-1055 , lot# 3087211.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2022 -00432.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records relevant to the right total hip arthroplasty identified the following: the right total hip arthroplasty appears intact.No bone or hardware fracture.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.
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