(b)(4).Concomitant medical products: medical product: oxf twin-peg cmntd fem lg pma catalog #: 161470 log #: 686070, medical product: oxf anat brg rt lg size 5 pma catalog #:159584 log #: 843210.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2019 -00520 and 3002806535-2019-00521.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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, g4, g7, h1, h2, h6, h10.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 which could be related to the reported event.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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