It was further reported that a patient had a revision on their left distal humerus approximately 7 years ago, due to malunion and loosening.Subsequently, the plating system is completely loose, making all movement painful.Later, at a clinic appointment, the surgeon identified an area of nonunion.It is intended for the patient to undergo a revision.The hospital has had to cancel the surgery multiple times and the next revision date was set for 2 years afterward.Attempts have been made and there is no further information at this time.
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This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports:0001822565-2023-01133, 0001822565-2023-01134, 0001822565-2023-01135, 0001822565-2023-01136, 0001822565-2023-01137, 0001822565-2023-01138, 0001822565-2023-01139, 0001822565-2023-01140, 0001822565-2023-01141, 0001822565-2023-01142, 0001822565-2023-01143, 0001822565-2023-01144, 0001822565-2023-01145, 0001822565-2023-01146.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2017: xray shows fixation intact- sign of bone healing.06-apr-2017: metalwork is completely loose and there are signs that the fracture itself has now healed.Will rule out infection prior to removal of hardware.(b)(6) 2017: there is miserable discomfort in her arm with all movement of the elbow.There are no signs of infection.Ct ordered for signs of progression towards union.(b)(6) 2018: multiple cancellations of surgery dates due to non-patient related events.Currently planned date of surgery is (b)(6) 2018.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: extensive screw loosening of both the original humeral orif and subsequent revision with fracture non-union and malalignment as described.Initial bone quality was mildly osteopenic with marked progression over time to severe osteopenia.The oblique nature of the original fracture and the osteopenia could contribute to the hardware failure and non-union of the bone fracture.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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