Catalog Number 150600003 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 02/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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Medical records received 17 june 2019 and were reviewed 17 september 2019 for mdr reportability.On (b)(6) 2015 the patient underwent total right knee arthroplasty due to rheumatoid arthritis and osteoarthritis of the right knee.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and unknown bone cement.On (b)(6) 2018, the patient underwent a right knee revision due to loosening, ankylosis, and pain.The surgeon indicated the tibial tray came unbonded at the tray to cement interface.There were no complaints against the femoral component, though it was revised.The surgeon reported the patella was not loose, it was not revised.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015 dor: (b)(6) 2018 (rt 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 : 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 will be filed as appropriate.
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Search Alerts/Recalls
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