Model Number 1506-00-005 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Code Available (3191)
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Event Date 09/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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On (b)(6) 2014, the patient underwent total left knee arthroplasty due to degenerative arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2019, the patient underwent a left knee revision due to loosening of the tibial component.The surgeon reported the tibial component was loose, with debonding at the cement to component interface.He noted the femoral component appeared to be intact and retained.The surgeon indicated the patella had minimal wear, solid, stable and was retained.The surgeon reported no intraoperative complications.The patient was implanted with attune knee revision tibial component and competitor cement.Doi: (b)(6) 2014.Dor: (b)(6) 2019, (lt knee).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 at this time.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 will be filed as appropriate.
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Search Alerts/Recalls
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