(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2017 - 09851, 0001825034 - 2017 - 09852, 0001825034 - 2017 - 09853, 0001825034 - 2017 - 09854, 0001825034 - 2017 - 09855, 0001825034 - 2017 - 09856, 0001825034 - 2017 - 09857.Concomitant medical products: dvr anatomic short right, unknown part/lot, multi directional screw, unknown part/lot, qty: 2, smooth peg, unknown part/lot, qty: 4, ulnar component, unknown part/lot.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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This follow-up report is being submitted to relay additional information.X rays were evaluated and the reported event was confirmed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.X-ray review confirmed fracture of the distal radius; it was fixed with volar plate and screws, and has healed with malalignment of the distal fracture fragment.Position of the plate and orientation of the screws suggests malalignment of the distal radius likely occurred postoperatively, possibly due to lack of adequate fixation or other etiologies such as trauma.Lack of fracture fixation could possibly be due to too short of distal radius volar plate without adequate plating proximal to the fracture site.A distal ulnar arthroplasty prosthesis is also present, the head of which abuts the proximal cortex of the lunate.There is subchondral lucency of the proximal lunate, as well as diffuse sclerosis of the lunate.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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