Medical records received 17 june 2019 and were reviewed 29 august 2019 for mdr reportability.On (b)(6) 2015, the patient underwent left knee arthroplasty due to varus osteoarthritis of the left knee.The surgeon reported no intraoperative complications.All attune components were utilized in the procedure.Competitor cement were utilized in the procedure.On (b)(6) 2017, the patient underwent a left knee revision due to loosening of the tibial component.The surgeon indicated the cement mantle was found to be loose at the tibial tray/cement interface.He noted a well-fixed femoral component, there were no complaints against the patella.The surgeon reported no intraoperative complications.All competitor components and cement 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 synthesof 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 : the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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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