(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz d rm pma catalog #: 154725 lot #: 437750, medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 015540.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00944, 3002806535-2019-00945.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz d rm pma, catalog #: 154725, lot #: 437750, medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 015540.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00944-1, 3002806535-2019- 00945-1.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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