(b)(4).Concomitant medical products: item#:154725 ;lot#:337110 ;item name: oxf uni tib tray sz d rm pma, item#:161469 ;lot#:737850 ;item name: oxf twin-peg cmntd fem md pma.Investigation of this incident is currently ongoing.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.The following sections were updated:b4, b5, g3, g6, h2,h3, h6, h10.Visual examination of the provided photograph identified signs of the bearing have being implanted, however, the photograph was not of sufficient quality to make the appropriate evaluation.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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