Model Number 1506-00-005 |
Device Problems
Loss of or Failure to Bond (1068); Migration (4003)
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Patient Problems
Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Fibrosis (3167); Joint Laxity (4526)
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Event Date 03/23/2021 |
Event Type
Injury
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Event Description
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Doi: (b)(6) 2016: patient received a right primary attune tka to treat sever tricompartmental osteoarthritis and osteophyte formation.The patella was resurfaced and competitor cement x 2 was utilized.The procedure was completed without complications.Clinic visit dated (b)(6) 2020: patient reports right knee medial side pain and walking difficulty.X-rays reveal varus collapse of tibial tray with lucency around the keel.Patient is referred to a reconstructive specialist for revision of the right knee.Doi: (b)(6) 2021: patient received a right knee revision to treat pain, instability, walking difficulty, and osteolysis secondary to loosening and collapse of the tibial tray.Upon entering the joint, the surgeon identified and debrided fibrosis and synovitis secondary to cement and polyethylene particle disease.The tibial tray had collapsed into varus and was loosened and debonded at the cement to implant interface.There was significant tibial osteolysis.There was medial wear on the revised tibial insert.The femoral component was well-fixed but revised.The patella was retained.The patient received a competitor revision construct.The procedure was completed without complications.Doi: (b)(6) 2016.Dor: (b)(6) 2021.Right knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions 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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary device associated with this report was not received for examination.All available photographs were reviewed and found burnishing on the implant, indicating micro motion.The present condition found can confirm loss of bond and movement.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 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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Search Alerts/Recalls
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