On (b)(6) 2023, a clindex notification was received indicating that a severe complication occurred of a patient listed on the shoulder arthroplasty registry.Patient underwent total shoulder procedure on (b)(6) 2020, in which the arthrex eclipse implant set was used.A year later, (b)(6) of 2022, patient presented pain and cuff dysfunction.A decision was made to convert the arthroplasty procedure to a reverse procedure on (b)(6) 2022.This is all the information provided at this time.Additional information received on 1/10/2023: during the original surgery on (b)(6) 2020, the following arthrex products were implanted: arthrex eclipse humeral head size 41x16mm, part number ar-9341-16, lot1911007.Arthrex eclipse cage screw medium, part number ar-9301-02, lot 18.01106.Arthrex eclipse trunion 39mm, part number ar-9301-39cpc lot 18.01134.Arthrex univers vault lock glenoid small, part number ar-9106-01, lot 1027261912.During the revision surgery, the following arthrex products were explanted: arthrex univers vault lock glenoid small, part number ar-9106-01, lot 1027261912.Arthrex eclipse humeral head size 41x16mm, part number ar-9341-16, lot 1911007.Arthrex eclipse cage screw medium, part number ar-9301-02, lot 18.01106.During revision surgery, the following arthrex products were implanted: modular glenoid central post, part number ar-9561-25p, lot 5436.Modular glenoid baseplate, part number ar9590-24-2, lot 14957770.Non-locking screw, part number ar9562-36n, lot number 2021005155.Locking screw, part number ar-9563-24, lot 14991605.Locking screw, part number ar-9536-16, lot number 14964000.Glenosphere, part number ar9564-t2433-lat, lot number 20.03005.Facility representative has corrected the revision surgery date to (b)(6) 2022.There was no complication while performing revision surgery.Both the original and revision surgery took place at the same facility and were performed by the same surgeon.
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