Batch review performed on 04-oct-2019: lot 155352: 50 items manufactured and released on 22-jun-2016.Expiration date: 11.Jan.2021.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs department: revision surgery performed 3, 5 years after cementless double-mobility total hip arthroplasty.In the radiographic image provided the cup looks horizontal and protruded in the pelvis.From this single pre-revision x-ray it is not possible to determine the primary position of the cup.Furthermore, no information concerning patient age and bone quality is available.The reason of this event cannot be determined.
|