Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07062, 0001825034-2017-09990, 0001825034-2017-09988, 0001825034-2017-09987.(b)(4).Concomitant products: catalog#010000589 comp rvrs 25mm bsplt ha+adptr lot# 588290.Catalog#115313 comp rvsr shldr glnsp +3 36mm lot#507470.Catalog# ep-115394 e1 44-36 std +3 hmrl brg lot#337240.Catalog# 115370 comp rvs tray co 44mm lot# 095430.Catalog# 113632 comp primary stem 12mm mini lot# 629610.Catalog# 115398 comp rvs cntrl 6.5x40mm st/rst lot#338580.Catalog#180553 comp lk scr 3.5hex 4.75x30 st lot#587170.Catalog# 180551 comp lk scr 3.5hex 4.75x30 st lot#320450.Catalog#180559 comp nlk scr 3.5hex 4.75x25 st lot# 073230.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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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