(b)(4).Concomitant medical products: 113633, comp primary stem 13mm mini, 730900; 115370, comp rvs tray co 44mm, 782800; xl-115366, acrom xl 44-41 std hmrl brng, 624930; 115320, comp rvrs shldr glnsp std 41mm, 976810; 010000589, comp rvrs 25mm bsplt ha+adptr, 563630; 115396, comp rvs cntrl 6.5x30mm st/rst, 323180; 180551, comp lk scr 3.5hex 4.75x20 st, 369350; 180550, comp lk scr 3.5hex 4.75x15 st, 502960; 180554, comp lk scr 3.5hex 4.75x35 st, 429640.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03473, 0001825034-2019-03475, 0001825034-2019-03476, 0001825034-2019-03477, 0001825034-2019-03478, 0001825034-2019-03479, 0001825034-2019-03482, 0001825034-2019-03483, 0001825034-2019-03484.Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.Reported event was confirmed by review of operative notes.Operative notes state the presence of hematoma and required medical intervention of open irrigation and debridement.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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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