BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORM. C/R TIB. BEAR.

    MDR report key: 404382 · Received July 11, 2002

    Report

    Report Number
    1825034-2002-00065
    Event Type
    Injury
    Date Received
    July 11, 2002
    Date of Event
    June 7, 2002
    Report Date
    July 1, 2002
    Manufacturer
    KIRSCHNER/BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE ARTHROPLASTY PERFORMED 09/1995. REVISION PERFORMED IN 2002, DUE TO REPORTED POLYETHYLENE WEAR OF TIBIAL BEARING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORM. C/R TIB. BEAR. PROSTHESIS, KNEE, COMP JWH KIRSCHNER/BIOMET, INC. NA 740L

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R