BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG FLUT FEMROD 5DG 16X 125MM

    MDR report key: 678147 · Received February 21, 2006

    Report

    Report Number
    1818910-2006-00506
    Event Type
    Injury
    Date Received
    February 21, 2006
    Date of Event
    January 27, 2006
    Report Date
    January 27, 2006
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN REVISED, DUE TO OSTEOLYSIS AND LOOSENING OF THE FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG FLUT FEMROD 5DG 16X 125MM TOTAL KNEE PROSTHESIS JWH DEPUY INTERNATIONAL, LTD. NA 243841

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention