(b)(4).Concomitant medical products: 110031427, cr vivacit-e 40mm brng std, 64354398.Item #: unknown, unknown humeral stem, lot #: unknown.Item #: unknown, unknown glenosphere, lot #: unknown.Item #: unknown, unknown glenoid baseplate, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.Reported event was confirmed by review of medical records and examination of device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the returned product and provided pictures identified a reverse shoulder mini humeral tray (part 110031404) was returned for evaluation.As returned, scratches were seen on the backside of the tray and the side/rim exhibits surface damage.Medical records reviewed by a health care professional identified the following: two views of the right shoulder demonstrate a reverse total shoulder arthroplasty with inferior positioning of the glenosphere.First image demonstrates possible dislocation of the glenohumeral joint and second image demonstrates implant disassembly with the humeral tray seen inferior and medial in position.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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