Model Number 1506-10-007 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Cyst(s) (1800); Pain (1994); Swelling/ Edema (4577)
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Event Date 04/22/2022 |
Event Type
Injury
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Event Description
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Clinical notification received for revision due to aseptic loosening.Date of implant: (b)(6) 2015.Date of revision: (b)(6) 2022.(left side).Treatment: removal of femoral component, tibial tray, and insert.
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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.
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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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Event Description
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On (b)(6) 2015, the patient had a left total knee replacement to address osteoarthritis of the left knee.Depuy components, including depuy patella were used during this procedure.On (b)(6) 2022, the medical records note the patient had pain and swelling.On (b)(6) 2022, the patient had a revision left total knee to address failure of fixation.Depuy products were used during this procedure.The indications for surgery included a ct-scan showing loosening of loosening of the tibial component.During the procedure, the surgeon observed debonding of the tibial tray and cement mantle.There was a large subchondral cyst in the lateral metaphysis of the tibia.The femoral component and insert were removed, without allegation of deficiency.
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Search Alerts/Recalls
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