Batch review performed on 26 june 2023: lot: 180667: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-02.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 medical affairs director: revision surgery 4 years and 4 months after primary tha due to hip instability.According to report, it was reported posterior subluxation at 50 degree hip flexion, 10 degree adduction and beyond 45 degrees of internal rotation due to bone to bone impingement anteriorly.From the preop image, the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.From the post-op radiographic image, a (presumably) intraoperative fracture solved with cerclage is visible but no information was given regarding this event.With the information at hand, the reason of this failure cannot be determined.Other device involved: cup: versafitcup 01.26.48mb acetabular shell ø 48 (k083116) lot: 178346: (b)(4) items manufactured and released on 14-mar-2018.Expiration date: 2023-03-04.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.
|