BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INS SZ4 12.5MM

    MDR report key: 1801219 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05059
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED UNANTICIPATED WEAR FOR A POLYETHYLENE DEVICE IMPLANTED FOR APPROXIMATELY 9-1/2 YEARS. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE LOT CODE. THE ROOT CAUSE IS BEING ATTRIBUTED TO THIRD BODY DEBRIS BEING INTRODUCED INTO THE JOINT SPACE RESULTING IN ACCELERATED MATERIAL WEAR. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR OSTEOLYSIS, POLYETHYLENE WEAR OF INSERT AND PATELLA; AND LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. REVISION SURGERY FOUND LOOSENING AT THE BONE/CEMENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INS SZ4 12.5MM JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 35867A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention