On 9/28/2022, it was reported by a sales representative via email that an a patient underwent a reverse modular shoulder procedure on (b)(6) 2020.During this procedure an ar-9501-13s apex humeral stem, an ar-9502f-39lcpc suture cup, an ar-9503m-03 humeral insert, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, an ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere, were successfully implanted.Two years later, on (b)(6) 2022, patient underwent a revision reverse total shoulder procedure because the central and peripheral screws broke off the baseplate.Additional information received on 9/30/2022: during revision surgery on (b)(6) 2022, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, and ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere were removed.Procedure was completed by implanting an ar-9502-39arca univers revers ca humeral head adapter from lot number 18.00756 and an ar-9550-19rca univers revers ca humeral head from lot number 10248799 were implanted.
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