The patient was revised to address pain.Patient presented with a sz 6 left attune ps femur with an attune revision tibia.Tibial side was well fixed and not revised.Doctor removed the sz 6 femur, which was cemented and well fixed.The poly removed was 6x14mm rp attune revision poly.Doctor then revised the femur with a 6 attune revision femur, 40mm femoral sleeve and a 12x60mm stem.No lot numbers were able to be visualized due to cement on the femur.All information that the doctors office has been provided.All information that was obtained from the revision surgery were provided.Original implant date is unknown.No loosening and no delay on surgery.Doi: unk.Dor: (b)(6) 2021; left knee.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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