(b)(4).Oxf anat brg lt sm size 5 pma, item# 159542, lot# 345740.Oxf twin-peg cmntd fem sm pma, item# 161468, lot # 480170.Multiple mdr reports were filed for this event, please see associated reports: 002806535 - 2024 - 00090.3002806535 - 2024 - 00091.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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This follow-up report is being submitted to relay additional information.No products were 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.With the available information, 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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