Patient received a left attune knee to treat degenerative joint disease.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 pain, osteolysis, tibial insert wear, tibial bone injury, tibial tray migration, and tibial tray loosening at the cement to implant interface.The surgeon noted the removal of fibrinous tissue as well as removal of meniscus of tissue that had developed around the poly patella component.The poly patella component was intact with very little wear and was retained.The tibial insert, tibial tray, and femoral component were revised.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2014, 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: 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).A manufacturing records evaluation (mre) was not performed.
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