Model Number 3092-040 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Scar Tissue (2060)
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Event Date 09/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.Dmf# - 13704, trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.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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Medical records received ad 07 dec 2021.Revision operative notes (b)(6) 2020 indicate the patient received a right total knee revision due to pain and loosening.Upon entering the joint, scar tissue was noted and removed.The tibial component was noted to be loose at the cement to implant interface.Femur, tibia and insert revised, competitor products including cement implanted at this revision.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2014.Dor: (b)(6) 2020, (right knee).
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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 : (dhr review captured from (b)(4)) a review of the manufacturing records evaluation (mre) was performed as part of the investigation on 13 april 2021, 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4) units released.
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Search Alerts/Recalls
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