(b)(4).Concomitant medical products: 113952,modular hybrid glenoid base, 932710, pt-113950,modular hybrid glenoid post¿regenerex, 573810, 113032,versa-dial humeral head, 842820, 118001,versa-dial/comp ti std taper, 076840.Report source: (b)(6).Complaint sample was evaluated and the reported event was not confirmed.As per the operative records and x-rays provided, the rotator cuff was normal.Humeral head had normal contour and the glenoid was normal.There were no complications, deviations from surgical technique, or delays in the procedure.As per the x-ray review of 6-months post initial surgery, no glenoid and humeral radiolucency, subsidence, osteolysis, migration, integrity is intact and no bone fracture.Dhr was reviewed and no discrepancies were found.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: 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388, 0001825034 - 2019 - 02389, 0001825034 - 2019 - 02385.
|
It has been reported that patient had initial comprehensive shoulder arthroplasty.Subsequently, patient suffered shoulder pain, instability, tenderness, decrease in adls and impingement.No additional patient consequences were reported.
|