BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 374542 · Received January 25, 2002

    Report

    Report Number
    MW1023947
    Event Type
    Malfunction
    Date Received
    January 25, 2002
    Date of Event
    November 12, 2001
    Report Date
    January 24, 2002
    Manufacturer
    BIOMET
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TOTAL RIGHT KNEE REPLACEMENT. RECENT RECURRENCE OF PAIN IN RIGHT KNEE WITH SYNOVITIS. HAD REPLACEMENT OF THE TIBIAL COMPONENT OF TOTAL KNEE. COMPONENT SENT WITH REP AFTER STERILIZATION. ORIGINAL IMPLANT KNEE AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TIBIAL COMPONENT OF TOTAL KNEE HSH BIOMET 11-146136 16MM X 63/67MM 878710

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR