Model Number 3102-080 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Pain (1994); Synovitis (2094); No Code Available (3191)
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Event Date 06/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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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Knee revision - attune tka.Patient underwent a left total knee arthroplasty due to left knee osteoarthritis and pain.Depuy cement x1 was utilized during surgery.The patient had a left knee revision arthroplasty of tibial component to address pain, loosening of tibial tray at bone/tray interface, and arthrofibrosis.During the procedure, the surgeon noted effusion and moderate synovitis.There were no allegations of deficiency of the femoral component, insert or patella.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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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