(b)(4).It was indicated that the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-09812.
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It was reported that the surgeon experienced a problem assembling the humeral bearing with the baseplate during a reverse total shoulder arthroplasty.As a result, the poly experienced damage near the locking mechanism of the baseplate and the locking ring experienced damage as well.Following a 5 minute delay, the surgeon opened new components and experienced no further problems.
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(b)(4).Concomitant medical products: arcom xl 44-36 std hmrl brng lot#812440 item#xl-115364, comp primary stem 11mm mini lot#546700 item#113631, comp lk scr 3.5hex 4.75x30 st lot# 061500 item#180553 , comp lk scr 3.5hex 4.75x20 st lot#817520 item#180551, comp rvrs shldr glnsp std 36mm lot#343450 item#115310, comp nlk scr 3.5hex 4.75x25 st lot#820720 item#180559, comp rvrs 25mm bsplt ha+adptr lot#996420 item#010000589, comp rvs cntrl 6.5x40mm st/rst lot#991060 item# 115398, comp.Rev shldr 9 in steinmann lot#871200 item# 405800.The reported complaint is confirmed as the visual inspection of the returned products revealed that the locking ring was bent and the poly showed scratches.The marking/identification was also illegible.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Compatibility check noted no issues.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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