BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET, INC

    MDR report key: 450210 · Received March 25, 2003

    Report

    Report Number
    450210
    Event Type
    Malfunction
    Date Received
    March 25, 2003
    Date of Event
    January 8, 2003
    Report Date
    March 24, 2003
    Manufacturer
    BIOMET INC
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REVISION OF LEFT KNEE TOTAL ARTHROPLASTY. IRREGULAR WEAR NOTED ON TIBIAL BEARING AND COMPONENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET, INC MAXIM PRIMARY TIBIAL BEARING 12 X 71/75MM HSH BIOMET INC 146152 923060

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other