Batch review performed on (b)(6) 2023.Lot 2103988: 240 items manufactured and released on 27-may-2021.Expiration date: 2026-05-10.No anomalies found related to the problem.To date, 217 items of the same lot have been sold with no similar reported case during the period of the review.Additional device involved.Batch reviews performed on 20-jul-2023: reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2118705: 89 items manufactured and released on 14-feb-2022.Expiration date: 2027-01-27.No anomalies found related to the problem.To date, 87 items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 2113523: 70 items manufactured and released on 14-feb-2022.Expiration date: 2027-01-27.No anomalies found related to the problem.To date, 61 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager on (b)(6) 2023: revision 1 year and 1 month after the primary rsa, due to a loose glenosphere and baseplate.As it is visible in the radiographic image, the most superior screw is broken.For unknown reasons the baseplate was not able to integrate and it may be possible that there was not primary stability.Therefore, in these conditions the screw could not indefinitely support the implants and it broke.It may be possible that due to the loosening an impingment between the humerus implant and the glenosphere might have happened.
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At about 1 year and 1 month after the primary, the patient came in reporting pain due to a loose baseplate, which had also not integrated with the bone.Upon opening the patient, it was also noted that one of the two l30 screw had broken (it is unknown which one broke).The surgeon revised successfully all components with competitor components.
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