(b)(4).Medical devices: 180551, comp lk scr 3.5hex 4.75x20 st, 731520; 180557, comp nlk scr 3.5hex 4.75x15 st, 452670; 115382, comp rvs cntrl scr 6.5x30mm st, 877000; 010000589, comp rvrs 25mm bsplt ha+adptr, 246500; 115370, comp rvs tray co 44mm, 848480; 113618, comp primary stem 18mm micro, 661170; xl-115363, arcom xl 44-36 std hmrl brng, 478500; 405889, comp rvs 2.7mm dia drl, 055780; 115310, comp rvrs shldr glnsp std 36mm, 933470; 180557, comp nlk scr 3.5hex 4.75x15 st, 452670; 405800, comp.Rev shldr 9 in steinmann, 132910; 180551, comp lk scr 3.5hex 4.75x20 st, 731520; 180551, comp lk scr 3.5hex 4.75x20 st, 664220; 405883, comp rvs 3.2mm drl, 04_310; customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03159; 0001825034 - 2018 - 03161; 0001825034 - 2018 - 02448; 0001825034 - 2018 - 02449.
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It was reported by the patient¿s legal counsel that the patient underwent right shoulder arthroplasty.Subsequently, the patient was revised due to a central screw fracture, a loose glenosphere, and screw migration.Attempts have been made and additional information on the reported event is unavailable.
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It was reported by the patient¿s legal counsel that the patient underwent right shoulder arthroplasty.Subsequently, the patient was revised due to a central screw fracture and a loose, disassociated glenosphere.During the revision, it was found that the screws had migrated and cut out the posterior glenoid.The patient was converted to a hemi-arthroplasty.Attempts have been made and additional information on the reported event is unavailable.
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