(b)(4).Medical devices: unknown femoral, catalog#: ni, lot#: ni, unknown tibial insert, catalog#: ni, lot#: ni.Foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its current location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay corrected and additional information.Corrected: b3, d6b.B3 event date: event date is unknown as the revision has been postponed d6b: there is no explant date.The device remains implanted.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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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