(b)(4) concomitant medical products: 118001, comprehensive versa-dial/comp ti std taper, 780060.The 115370, comp rvs tray co 44 mm, 654490.The 113654, comp primary stem 14 mm std, 287120.The ti-115313, comp vrsdl glnspr 36 mm +3 ti, 799480.The xl-115364, arcom xl 44-36 std +3 hmrl brg, 256230.The 115395, comp rvs cntrl 6.5 x 25 mm st/rst, 711530.The 180559, comp nlk scr 3.5 hex 4.75x25 st, 916660.The 180560, comp nlk scr 3.5 hex 4.75x30 st, 900470.The 180559, comp nlk scr 3.5 hex 4.75x25 st, 150290.The 180552, comp lk scr 3.5 hex 4.75x25 st, 653810.Reported event was confirmed by review of the provided revision op notes.Per the revision operative report, pre-op x-rays confirmed that the glenosphere had pulled out of the baseplate.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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: 0001825034-2018- 02403.
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