(b)(4) multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2018-01404, 0001825034-2018-01405, 0001825034-2018-01407, 0001825034-2018-01408.Concomitant medical products: 113631 comp primary stem 11 mm mini lot 958170, 115340 comp rvs hmrl ti tray 44 mm lot 266170, 115310 comp rvrs shldr glnsp std 36 mm lot 183450, 010000589 comp rvrs 25mm bsplt ha+adptr lot 566470m 115381 comp rvs cntrl scr 6.5 x 25 mm st lot 424370mm 180503 comp locking screw 4.75 x 30 mm lot 801940, 180504 comp locking screw 4.75 x 35 mm lot 460530, 180513 comp non-lckng screw 4.75 x 45 mm lot 402380.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends 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.Device remains implanted.
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It was reported in clinical study (b)(6) the patient had pain 3 years post total shoulder arthroplasty.The pain was reported at a level of 7 on a scale of 10 and the patient took non-narcotic pain medication for this.The patient was unable to sleep on the affected side, unable to wash their back, unable to lift 10 pounds above their shoulder, unable to throw a ball and unable to do sports.Attempts have been made and no further information has been made available at this time.
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