(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034-2019-02456, 0001825034-2019-02457, 0001825034-2019-02458, 0001825034-2019-02459.Concomitant medical products: 115330, lot 410400 comp rvrs shdr glen 28mm bsplt +ha, udi #: (b)(4).180550, lot 540630, comp lk scr 3.5hex 4.75x15 st, udi #: (b)(4).115396, lot 479990, comp rvs cntrl 6.5x30mm st/rst, udi #: (b)(4).180550, lot 432280, comp lk scr 3.5hex 4.75x15 st, udi #: (b)(4).180550, lot 540690, comp lk scr 3.5hex 4.75x15 st, udi #: (b)(4).180551, lot 372480, comp lk scr 3.5hex 4.75x20 st, udi #: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: device remains implanted.
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This follow-up report is being submitted to relay additional information.No device was returned for evaluation.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Medical records were not provided.However, it was reported the patient fell causing the patient glenoid to fracture and the construct to pull away.The root cause of the reported issue is attributed to human factor issue.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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