(b)(4).Device product code - phx.Concomitant medical devices: part# 180555; lot# 018400; part# 180555; lot# 018410; part# 180556; lot# 232620; part# 180555; lot# 283200; part# 115310; lot# 141420; part# 113613; lot# 923000; part# 110031399; lot# 64682740 part# 110031418; lot# 64578844; part# 110027734; lot# 600120; part# 110031378; lot# 600150.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the first available pre-revision post op record identified the following: limited examination secondary to suboptimal positioning.Also, there is grid artifact which further limits evaluation.The articular region of the arthroplasty is not well characterized and overall, the glenosphere is limited in evaluation.Grossly normal alignment.Hardware appears grossly intact.No obvious periprosthetic lucency or hardware fracture.The glenosphere screws appear intact.Bones appear intact without fracture.Subcutaneous/soft tissue emphysema noted in the axillary region and in the soft tissues surrounding the humerus.Review of the second available pre-revision post op record identified the following: disassociation of the glenosphere with the outer component displaced to the level of the proximal humerus diaphysis.The humerus is therefore not in alignment with the glenoid component and is located superior and lateral to the glenoid.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error as the central screw was not fully seated.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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