BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFK MODULAR KNEE SYSTEM CURVED TIBIAL INSERT

    MDR report key: 389450 · Received April 18, 2002

    Report

    Report Number
    1818910-2002-00207
    Event Type
    Injury
    Date Received
    April 18, 2002
    Date of Event
    May 20, 2002
    Report Date
    April 18, 2002
    Manufacturer
    DEPUY-RAYNHAM
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WILL BE REVISED FOR OSTEOLYSIS AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFK MODULAR KNEE SYSTEM CURVED TIBIAL INSERT TOTAL KNEE PROSTHESIS JWH DEPUY-RAYNHAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R