It was reported that (b)(6) 2019 a patient had a reverse shoulder procedure.On (b)(6) 2020 the patient underwent a revision surgery.The patient had an autograft to the glenoid on her initial surgery and it did not appear to have healed.The sales representative who was present during the revision reports that the surgeon had mentioned in surgery that he believed that the locking mechanism on the baseplate may not have been functioning appropriately (the screw was not locked in).During the original procedure the following arthrex devices had been implanted: ar-9564-2436-lat, glenosphere, lot 18.00689.Ar-9503s-03, humeral insert, lot 18.00870.Ar-9502f-36cpc, univers revers suture cup, lot 170141708.Ar-9561-25p, modular central post, lot 5368.Ar-9560-24-2, modular baseplate, lot 5408.Ar-9562-36nl, peripheral screw non-locking, lot 2018001207.Ar-9563-36, peripheral screw locking, lot 2018001490.Ar-9563-40, peripheral screw locking, lot 2018001491.Ar-9501-12p, univers revers humeral stem size 12, lot 170125705.During the revision surgery all off the above listed original implants were explanted, except for the ar-9501-12p, univers revers humeral stem size 12, which was left in the patient.Explanted devices will be returned for evaluation.The surgeon completed the revision by doing a hemi arthroplasty and implanting the following arthrex products: ar-9502-36arca, revers ca adapter assembly, lot 18.01305.Ar-9544-17rca, revers ca humeral head, lot 10071302.Ar-9502f-36cpc, univers revers suture cup, lot 19.00846.The original and revision procedures were performed by the same surgeon at the same facility.
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