BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS, INC.

    MDR report key: 805042 · Received January 12, 2007

    Report

    Report Number
    MW1041615
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    December 5, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USUAL PREPARATION AND MEASURING OF FEMORAL AND TIBIAL IN THE RIGHT KNEE, HOWEVER, WHEN PLACING THE TIBIAL COMPONENT IT BASICALLY FELL INTO THE HOLE WITH ESSENTIALLY NO PURCHASE ON SURROUNDING BONE. FIRST TIME USE OF VANGUARD SYSTEM WHICH WAS SUPPOSED TO INTERCHANGE WITH MAXIM STYLE TRAYS. ABORTED THIS PROCESS, INCREASED TOURNIQUET TIME PASSED AND WENT TO THE LEFT. DID SAME PROCEDURE USING MAXIM TRAY WHICH FIT. TRIED VANGUARD AND IT WAS AGAIN TOO LOOSE. FIT SIZE IS DIFFERENT. CLOSED AFTER COMPLETING AND BACK TO RIGHT. MADE SAME ADDITIONAL REPAIRS TO MAKE FOR A BETTER FIT. INFORMED BY REP (PRESENT) TIBIAL COMPONENTS NOT INTERCHANGEABLE. CALLED ENGINEER AT BIOMET-KNEE UNCHANGED. EXCHANGED TO VANGUARD ON RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC. IMPLANT FOR KNEE ARTHROPLASTY-TOTAL KNEE JWH BIOMET ORTHOPEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention