Batch review performed on 2 april 2023: lot 2243239: (b)(4) items manufactured and released on 14-feb-2023.Expiration date: 2028-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medacta medical affairs manager: revision surgery 2 months after primary tha due to shell mobilization in a 64 year old female patient.The surgery was completed successfully.From the radiographic images, the acetabular cup appears to have mobilized.In these conditions, it is very likely that part of the femoral stem may impinge with the acetabular rim and damage may occur.The cup has not found pressfit and primary stability and the reason of this event is unknown.
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