Cmp-(b)(4).D10 - medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 120460, oxf twin-peg cmntd fem sm pma; item# 161468; lot# 857450.Multiple mdr reports were filed for this event, please see associated report: 3002806535 - 2023 - 00441, 3002806535 - 2023 - 00442.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 information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause could not 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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