(b)(6).The reported event was identified during review of a journal article wiater, michael, sheilds edward, koueither, denise, schwark, adam (2017) previous rotator cuff repair is associated with inferior clinical outcomes after reverse total should arthroplasty.The orthopaedic journal of sports medicine 5(10).Https://www.Ncbi.Nlm.Nih.Gov/pubmed/29051900.Concomitant: unknown trabecular metal base plate; unknown trabecular metal glenoid head; unknown trabecular metal poly liner.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 07836, 0001822565 - 2017 - 07837, 0001822565 - 2017 - 07838.
|