Dor: (b)(6) 2021.Patient received a left knee revision to treat pain, swelling, stiffness, and instability secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and debrided scar tissue.The tibial tray was loose at an unknown interface and revised.The femoral component was revised to accommodate the revision construct.The patella was retained.There was no reported product problem with the revised tibial insert.The patient received a competitor revision construct secured with competitor cement.The procedure was completed without complications.Mua: (b)(6) 2021.Patient received a manipulation under anesthesia for unknown reasons.No further information available.Doi: (b)(6) 2018, doe: (b)(6) 2018 (mua), dor (b)(6) 2021 ((b)(4) revision to competitor construct with retained patella), doe: (b)(6) 2021 (mua).
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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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