Batch review performed on 23 april 2021: lot 103104: (b)(4) items manufactured and released on 03-jan-2011.Expiration date: 2015-11-30 no anomalies found related to the problem.To date, all items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.Clinical evaluation performed by medacta clinical affairs director: femoral component (stem, head and liner) revision performed 9.5 years after primary cementless total hip arthroplasty in a (b)(6) year old woman.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, the stem looks loosened.It must also have migrated from the original position, but this cannot be determined because no radiographic history is available.There is no mention of a traumatic event, but we cannot exclude it happened.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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