(b)(4).Associated products list: item reference:161469, item name: oxf twin-peg cmntd fem md pma, lot number:216590.Item reference:154722, item name: oxf uni tib tray sz c lm pma, lot number:169180.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00364, 3002806535-2022-00365.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 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 related to the reported event.Devices are used for treatment.Medical records were not 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.
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