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 4 similar incidents (this incident included) related to post-operative loosening of a anatomic posterior stabilized femoral component cemented.The rate is (b)(4) (based on anatomic posterior stabilized femoral component cemented globale sales between 2013 and february 2023).The analysis of the recorded patient file during the patient clinical monitoring by the surgeon doesn't reveal any element which could explain the loosening of the femoral component.It was noted that the patient has obesity class i (bmi : 31.3).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 loosening after 5 years remains undetermined.
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