Batch review performed on 04 december 2023 lot 1910233: (b)(4) items manufactured and released on 31-march-2020.Expiration date: 2025-03-16.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision of the cup performed at about 2 years 2 months after the primary, due to medialization of the acetabular cup and suboptimal offset.According to report, there was no loosening nor infection.From the radiographic image, the cup seems slightly medialized but the medial wall is intact.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.However, without a controlateral image it is difficult to evaluate the position of the cup.There is no reason to suspect a faulty device.
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At about 2 years 2 months after the primary, revision surgery performed on the left side due to medialization of the acetabular cup and suboptimal offset.Patient had discomfort since the primary surgery.No loosening of the implants.No infection.The surgeon revised successfully the cup, liner and head.
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