Batch review performed on 28-aug-2023.Lot 1910099: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Clinical evaluation performed by medical affairs department: early infection in cementless rsa, 1 month and 2 weeks after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other devices involved: reverse shoulder system 04.01.0111 humeral reverse metaphysis +9mm/0° (k170452) lot 2001817: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-07-02.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.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot 2248488: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-04-12.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.
|