BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. CRUC SACR FEM SIZE-3

    MDR report key: 1210525 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04689
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K931466
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL INSERT DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. CRUC SACR FEM SIZE-3 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 865AU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention