At about 2 years and 2 months after the primary surgery, the patient came in reporting pain.Scapular notching was observed on x-rays.The surgeon performed an arthrotomy with soft tissue/fluid testing for infection and revised the glenosphere, metaphysis and liner.The surgery was completed successfully.
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Batch review performed on 28-nov-2022: lot 1908971: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-oct-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 2 years and 2 months after the surgery.The patient reported pain.From radiographic images, scapular notching is observed in the distal aspect of the bone.The surgeon performed an arthrotomy with soft tissue/fluid testing for infection and revised the glenosphere which was substituted with a lateralized one, metaphysis and liner.The surgery was completed successfully.Other devices involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 1908252: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-mar-01.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 183537: (b)(4) items manufactured and released on 15-oct-2018.Expiration date: 2023-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
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