Patient received a left attune knee to treat severe osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address tibial tray loosening at the cement to implant interface, severe tibia bone loss, tibial tray migration, removal of dense scar tissue, instability, and distal and femoral bone somewhat compromised from significant osteolysis particularly the posterior condyles.The tibial tray, tibial insert, and femoral component were revised.After removal of heterotopic bone and dense scar tissue, the well-fixed patella component tracked well and was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2015.Dor: (b)(6) 2020; left 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 previous dhr review was conducted for (b)(4) against the provided smartset gmv 40g us eo product code 545050501, lot 8068693 combination.A device history record (dhr) review per (b)(4) found two unrelated non conformances on this batch.Micro and sterility tests passed.
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