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 since 2014 show 7 similar incidents for loosening on anatomic® tibial component cemented (the rate is 0.0096%).The analysis of the patient follow-up performed by our marketing teams doesn't reveal any element which could explain the loosening of the tibial baseplate.It was noted at 1 month patient follow-up (in (b)(6) 2023) a baseplate sinking on the internal side.Without explant, reference and batch number, no further investigation can be performed.In conclusion and according to the elements in our possession, the origin of the loosening after 3 months remains undetermined.If any further information is found which would change or alter any conclusions, a supplemental report will be filed accordingly.
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