Medical records received 17 june 2019 and were reviewed 28 august 2019 for mdr reportability.On (b)(6) 2015, the patient underwent left knee arthroplasty due to osteoarthritis.The surgeon reported no intraoperative complications and patient was transferred to recovery in stable condition.Attune components, and two smartset cements were utilized in the procedure.On (b)(6) 2017, the patient underwent a left knee revision due to failed knee arthroplasty.The surgeon reported the tibial component was grossly loose and had de-boned at the tibial tray to cement interface.He also noted significant osteolysis in the interface of the tibial bone to cement.The surgeon indicated there were signs of particle disease with proliferation of synovium.He noted the femur component was stable.The surgeon reported no intraoperative complications.Attune components were utilized in the procedure.Doi: (b)(6) 2015.Dor: (b)(6) 2017, (lt knee).
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Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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