Batch review performed on 23 february 2024 lot 160097: (b)(4) items manufactured and released on 29-apr-2016.Expiration date: 2021-04-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: revision of the cup 7 years and 7 months after index surgery due to malposition of the cup and it went through the inner wall of the acetabulum.According to report, the cup became loose and then protruded in the acetabular wall.Post-op images after the index surgery were not provided.Lack of information and history prevents a thorough analysis to be performed.Progressive migration of the cup after almost 8 years is a rather unusual event, however it may be a consequence of aseptic loosening, a phenomenon described in literature, whose causes often remain undetermined.No reason to suspect a faulty device.
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