Batch review performed by medacta regulatory affairs department on 26 may 2020: lot 121496: (b)(4) items manufactured and released on 2-jul-2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event since 2016.Clinical evaluation performed by medical affairs director: planned stem revision 6 years and 7 months after primary cementless total hip arthroplasty.No information concerning patient age, general health status or activity level is available.In the radiographic image provided, radiolucent lines are visible and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
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