Batch review performed by medacta regulatory affairs department on 06.04.2021: lot 113031: (b)(4) items manufactured and released on 20-dec-2011.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events since 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem, head and liner) revision performed 9 years after primary cementless total hip arthroplasty in a (b)(6) year old, heavy ((b)(6) kg) man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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.Preliminary investigation performed by r&d project manager: looking at the image to the complaint it is visible that the whole ha coating has been absorbed by patient bone as expected.No particular signs of scratches or damages are present on the expianted stem.It is not possible to determine the root cause of the reported loosening.
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