Batch review performed on 28 novemeber 2023 lot 2306000: (b)(4) items manufactured and released on 06-jun-2023.Expiration date: 2028-05-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision surgery almost a month after the primary cemented tha due to loosening of the stem.It may be possible that the interdigitation of cement in the bone did not achieve strong fixation.We cannot determine the causes of this condition, but we see no reason to think that the prosthetic implant was defective.From the radiographic images the femoral fracture it is not visible but during the surgery, it was repaired with cable and a plate.Analysis performed by r&d manager: looking at the image attached to the complaint it is visible the stem covered with patient blood.The femoral head is still connected with the stem taper some signs and scratches are visible both on the stem body and on the head probably due to revision surgery.From the image attached it is not possible to add other hypotesis of the stem failure, the root cause remains unknown.
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