Batch review performed on 10 november 2023: lot 131157: (b)(4) manufactured and released on 22-may-2013.Expiration date: 2018-apr-30.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department: revision 10 years and 4 months after primary tha.From the radiographic images, radiolucent lines in zone 1 are visible.The position of the cup seems suboptimal.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.Signs of initial osteolysis are visible in zone 7 and 1.Aseptic loosening is a possible literature-described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason for this failure cannot be determined.Preliminary investigation performed by r&d project manager: looking at the image attached to the complaint it is visible that the stem is covered with patient blood.It seems that the whole ha coating on the stem body has been absorbed by the patient's 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.Some signs of minor damage and scratches are present on the neck of the explanted stem, likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and the information available, it is not possible to identify the root cause of the reported complaint.Additional involved implants: batch review performed on 10 november 2023 on ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.115751 lot 115751: (b)(4) manufactured and released on 25-jan-2012.Expiration date: 2016-dec-31.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.Batch review performed on 10 november 2023 on liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e (k103352) lot.120079 lot 120079: (b)(4) manufactured and released on 15-mar-2012.Expiration date: 2017-jan-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.
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