BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET, INC

    MDR report key: 559643 · Received December 3, 2004

    Report

    Report Number
    559643
    Event Type
    Injury
    Date Received
    December 3, 2004
    Date of Event
    October 15, 2004
    Report Date
    October 29, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HOSPITAL FOR REMOVAL AND REPLACEMENT OF RIGHT TOTAL KNEE SECONDARY TO SEVERE DEGENERATION OF THEIR POLYETHYLENE AND SUBSEQUENT TO THAT LIKELY COMPLETE POLYETHYLENE FAILURE WITH METAL ON METAL IRRITATION. PT'S KNEE WAS SWOLLEN. PT REQUESTED TO KEEP THEIR EXPLANTED TOTAL KNEE COMPONENTS. PT'S REQUEST WAS HONORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET, INC RIGHT TOTAL KNEE PROSTHESIS, MODULAR FINNED STEM 46MM X 4MM HSA BIOMET, INC. * 653080
    2 BIOMET, INC. RIGHT TOTAL KNEE PROSTHESIS, TIBIAL II BASE 79MM HSH BIOMET, INC. * 059430
    3 BIOMET, INC. RIGHT TOTAL KNEE PROSTHESIS, FEMORAL COMPONENT 70MM HSH BIOMET, INC. * 302310
    4 BIOMET, INC. RIGHT TOTAL KNEE PROSTHESIS, BUTTON 34MM HSH BIOMET, INC. * 227740
    5 BIOMET, INC. RIGHT TOTAL KNEE PROSTHESIS, TIBIAL II BEARING INSERT 12MMX7 HSH BIOMET, INC. * 155692

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention