Batch review performed on 29 november 2023: lot 145915: (b)(4) items manufactured and released on 20-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Investigation performed by medacta r&d hip project manager: looking at the image attached to the complaint it is visible the stem covered with patient blood.It seems that whole the ha coating on the stem body has been completely absorbed by patient bone.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.The femoral head has been disconnected from 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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At about 8 years and 11 months from the primary, the patient's x-rays showed thickening of the cortical walls at the distal part of the stem which is caused by the stem being loose.The surgeon removed the cocr head, the quadra-h stem and replaced it with a zimmer stem.Surgery completed successfully.
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