BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC-S MOD. TIB. BEARING

    MDR report key: 302325 · Received October 26, 2000

    Report

    Report Number
    1825034-2000-00076
    Event Type
    Injury
    Date Received
    October 26, 2000
    Date of Event
    September 13, 2000
    Report Date
    October 25, 2000
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED 1999. DUE TO PAIN, REVISION PERFORMED ON ELEVEN MONTHS LATER. WEAR WAS NOTED ON THE ARTICULAR SURFACE OF THE TIBIAL BEARING AND ALL COMPONENTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC-S MOD. TIB. BEARING PROSTHESIS, KNEE, COMP JWH BIOMET, INC. NA 888400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R