No review of manufacturing history records could be performed as the list of devices was not communicated by the healthcare facility.The review of the internal vigilance database shows 2 incidents related to post-operative pain with anatomic prothesis.The rate is (b)(4) (based on anatomic femoral component globale sales between 2013 and november 2023).It was noted that both incidents were reported by the same healthcare facility.The analysis of the patient file recorded during the clinical monitoring doesn't reveal any element which could explain the post-operative pain.It was noted in the clinical file that during the 11-months and 17-months follow-up visits that the patient was not satisfied (disappointed).Without explant, reference, batch number, x-rays, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the post-operative pain cannot be explained.
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Unexplained pain on anatomic® tka (posterior stabilized femoral component cemented size 1 and anatomic® tibial base plate for fixed bearing insert cemented size 0), 67 months after the implantation.The incident was detected during the patient clinical monitoring by the surgeon on november 23th 2023.The implantation was performed on (b)(6) 2018.Associated device: anatomic® posterior stabilized femoral component cemented, size 1 (reference and batch number not communicated).Anatomic® tibial base plate for fixed bearing insert, size 0, cemented (reference and batch number not communicated).Anatomic® fixed bearing insert size 0, thickness 12 (reference and batch number not communicated).
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