(b)(4), udi #: (b)(4).Concomitant medical products: comprehensive reverse shoulder bearing catalog # ep115361 lot # 429540.Comprehensive reverse shoulder glenosphere mini baseplate with taper adapter catalog # 010000589 lot # 193550, comp rvrs shldr glnsp std 41mm catalog # 115320 lot # 352060 , comp rvs cntrl 6.5x45mm st/rst catalog # 115399 lot # 57347, comp lk scr 3.5hex 4.75x35 st catalog # 180554 lot # 700070, comp lk scr 3.5hex 4.75x35 st catalog # 180554 lot # 466990 , comp lk scr 3.5hex 4.75x20 st catalog # 180551 lot # 993730, comp lk scr 3.5hex 4.75x20 st catalog # 180551 lot # 807940 , comp primary stem 16mm mini catalog # 113636 lot # 882800.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2019-04116.Product location is unknown.
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It was further reported through patient¿s medical records that prior to the revision procedure, the patient underwent home therapy to try and resolve the reported adverse events.However, this was unsuccessful and therefore, the revision procedure was performed.The bearing and tray were removed and replaced.
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