This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 d11 unknown humeral component unknown ulnar component unknown stems (2) unknown bearings the reported event was confirmed by a review of pictures and x-rays.Visual examination of the provided pictures identified that the bushing and pins are explanted and have bloodstains.The bushings appear to be fractured.The prongs of the inner pin are fractured.A review of the x-rays identified implant disassembly of a right total elbow arthroplasty at the hinge mechanism with the fractured pin within the antecubital fossa.Possible fracture of the olecranon and loosening of a radial intramedullary rod.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The 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: 0001822565-2020-00750 h3 other text : discarded.
|