Patient received a right attune knee to treat osteoarthritis.The patella was resurfaced and depuy cement was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, instability, flexion deformity, and tibial tray loosening at the cement to implant interface and bone to cement interface.Prior to revision the patient tested positive for nickel sensitivity and did have some patella baja.Due to the patella baja, the surgeon wanted to dislodge the joint line and did so with the use of augments.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.(b)(6) 2014.(b)(6) 2020.Right knee.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
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