It was reported that this patient had a right total attune knee with laxity.Dr.L.Did the knee and it was unknown when it was done.The surgeon planned on putting in a thicker tibial insert to tighten up the laxity but when the surgeon tapped on the femur and tibial tray, they both came out with multiple taps.There was cement on the backside of the femur, and no cement stuck to the backside of the tibial tray.The patella was well fixed and retained.The femoral component and tibial component were revised.Loosening was noted of the femur at the cement to bone interface and loosening of the tibia at the cement to implant interface.Unknown bone cement was used.There was no surgical delay.Doi: unknown.Dor: (b)(6) 2022.Affected side: right 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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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