Complaint sample was evaluated and the reported event was not confirmed.Per indicated that after reviewing the procedure with the sales representative present during the occurrence was unable to pin point when the ring became hung-up in the tray.At some point after shipment accidental mechanical damaged occurred.The dimensional sheet found all mating features within specification.The dimensions were taken where mechanical damaged had not occurred.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to customer preference.Completion of investigation relayed to sales rep via email.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under section 3.1.1: "humeral bearing does not assemble to humeral tray." 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.Multiple mdr reports were filed for this event, please see associated reports: 1825034 ¿ 2017 ¿ 07923 / 07938 / 07939.
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It was reported that during an initial reverse shoulder arthroplasty on (b)(6) 2015, while attempting to put the bearing in place, bearing was flush with the tray, however, the locking ring would not lock.Another locking ring was used with the same results, the surgeon then tried using a different poly but again, the same thing happened.The surgeon completed the procedure with a +5 tray and a +3 bearing.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
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