(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00138, 0001822565-2023-01133, 0001822565-2023-01134, 0001822565-2023-01135, 0001822565-2023-01136, 0001822565-2023-01137, 0001822565-2023-01139, 0001822565-2023-01140, 0001822565-2023-01141, 0001822565-2023-01142, 0001822565-2023-01143, 0001822565-2023-01144, 0001822565-2023-01145, and 0001822565-2023-01146.D10: distal medial humeral plate left 5 holes 104 mm length cat: 47235800805 lot: unk.Unknown plate.Unknown screws qty 12.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.(b)(6) 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 30-jul-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.H3 other text : product remains implanted.
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