Batch review performed on 18 october 2023: lot 2240583: (b)(4) items manufactured and released on 05-dec-2022.Expiration date: 2027-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical analysis performed by medical affairs department: revision after 11 days that was a result of a former revision rsa.The first revision was due to impingement and the second one is caused by dislocation after lifting a heavy weight.It may be possible that since not much time has passed from the first revision the luxation may be caused by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Other implant involved, batch review performed on 18 october 2023: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2241371: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
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The patient had a primary shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in for a post-op appointment and it was observed that the patient was experiencing impingement of the glenosphere on the scapula with scapula notching.The cause of this occurrence is unknown.The surgeon revised the glenosphere, metaphysis, and liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came reporting pain due to shoulder luxation after lifting a heavy weight.The surgeon removed the glenosphere, liner, metaphysis, glenoid baseplate and repositioned the baseplate more inferior on the glenoid.The surgery was completed successfully.
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