Batch review performed on 27 february 2024 lot 2209910: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-jun-09.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.Clinical evaluation performed by medical affairs department six months after primary rsa possibly originated by a fracture of the humerus tubercle the joint is significantly unstable the fracture is not healed and the humeral stem is loose.The situation clearly require a total revision but there is no reason to suspect a faulty device.Additional implant involved batch review performed on 27 february 2024 on reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot.2310548 lot 2310548: (b)(4) items manufactured and released on 01-jun-2023.Expiration date: 2028-may-14.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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