Batch review performed on 15 july 2022 lot 162985: 50 items manufactured and released on 12-aug-2016.Expiration date: 2021-jul-21.No anomalies found related to the problem.To date, 44 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta clinical manager: revision performed 5 years after primary cementless total hip arthroplasty in 60 years old man due to aseptic loosening.No information concerning patient general health status and the presence of comorbidities is available however, it is specified that the patient is a heavy working farmer.The femoral prosthesis explanted shows an impingement sign on the neck which must have been caused from impingement of the stem with the cup.In the radiographic image provided, the pre-revision posiotion of the cup seems to be different from post operative.This may be due to the cup having shifted because of impingement or, more likely, to a secondary tilting of the cup (perhaps due to a traumatic or quasi-traumatic event) which brought it in a position that caused impingement.Radiolucent lines and signs of stress shielding are visible, most likely a consequence of the impingement between femoral neck and cup rim.
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