The patient had a primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting instability and the cause of instability is unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to anterior subluxation of the reverse revision components.The surgeon revised the glenosphere, insert, and metaphysis.The surgery was completed successfully.
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Batch review performed on 5 december 2022 lot 2103687: (b)(4) items manufactured and released on 13-jul-2021.Expiration date: 2026-jun-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other device involved: batch review performed on 5 december 2022.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm lot.2103929 (k170452): (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-11.No anomalies found related to the problem.To date, (b)(4)items of the same lot have been sold with no similar reported event during the period of review.
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