(b)(4).Multiple mdr reports were submitted for this event.Please see reports: 0001825034-2017-07349, 0001825034-2017-07350.(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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This follow-up report is being submitted to relay additional information.Concomitant medical products: arcom xl humeral bearing, item # xl-115365, lot # 358590; comprehensive reverse primary stem 6 x 194, item # 113666, lot 503390; comprehensive reverse shoulder 9 in steinmann, item # 405800, lot 930600; comprehensive reverse tray +10mm co 44mm, item # 115378, lot 621420; comprehensive reverse lk screw 3.5hex 4.75x20 st, item 180551, lot # 196430; comprehensive reverse lk screw 3.5hex 4.75x20 st, item 180551, lot # 488590; versa-dial taper adaptor 25mm, item # 110031378, lot 716090; comprehensive reverse glen pps min tpr adr, item # 110027734, lot # 716060; comprehensive reverse scr 3.5hex 4.75x30 st # item 180553, lot # 333540; comprehensive reverse lk scr 3.5hex 4.75x35 st, item # 180554, lot 095420; comprehensive reverse cntrl 6.5x35mm st/rst, item # 115397, lot # 927940; comprehensive reverse bone and imp mdl, item # 110031178, lot # 716100.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-07349-2.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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