BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC-S MOD. TIB. BEARING

    MDR report key: 343133 · Received July 25, 2001

    Report

    Report Number
    1825034-2001-00067
    Event Type
    Injury
    Date Received
    July 25, 2001
    Date of Event
    June 14, 2001
    Report Date
    July 20, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRIMARY TOTAK KNEE ARTHROPLASTY PERFORMED 03/15/1995, WITH EXCHANGE OF THE TIBIAL BEARING IN 2000. DUE TO POLYETHYLENE WEAR, TIBIAL BEARING COMPONENTS WAS REPLACED ON EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33518 AGC-S MOD. TIB. BEARING PROSTHESIS, KNEE, COMP JWH BIOMET, INC. NA 116780

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R