Batch review performed on 06 april 2022: lot 152958: (b)(4) items manufactured and released on 07-oct-2015.Expiration date: 2020-09-12.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.Clinical evaluation performed by medacta medical director: about 7 years after primary cementless tha in an elderly lady, extensive radiolucent lines are visible on the radiogrphic control around the stem.In absence of a silent infection, this is probably a case of aseptic loosening, a possible adverse event following tha, described in literature.Causes remain often undetermined.We see no discernible clues that could point to a specific cause for this adverse event.
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