BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    MDR report key: 2141292 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10283
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: CATALOG #. EXAMINATION OF THE SUBMITTED PATELLA CONFIRMED ANTICIPATED WEAR FOR A POLYETHYLENE PATELLA KNEE DEVICE IMPLANTED FOR APPROXIMATELY 15-1/2 YEARS. BASED ON THE INVESTIGATIONS INABILITY TO IDENTIFY PRODUCT FAILURE OR PRODUCT CONTRIBUTION TO THE REPORTED EVENT, A 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER. OSTEOLYSIS AND POLYETHYLENE WEAR NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG, 41 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention