BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    MDR report key: 1801217 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05060
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    K961685
    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 PATELLA COMPONENT CONFIRMED ANTICIPATED 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 INVESTIGATION DID NOT FIND ANY EVIDENCE OF PRODUCT FAILURE OR PRODUCT ERROR 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/OV/DOME PAT 3PEG, 41 JWH DEPUY (IRELAND) NA 243826

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention