BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG FLUT FEMROD 5DG 16X175MM

    MDR report key: 650823 · Received December 9, 2005

    Report

    Report Number
    1818910-2005-02713
    Event Type
    Injury
    Date Received
    December 9, 2005
    Date of Event
    November 16, 2005
    Report Date
    November 16, 2005
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REVISED DUE TO BROKEN FEMORAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG FLUT FEMROD 5DG 16X175MM TOTAL KNEE REPLACEMENT JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention