BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS, INC

    MDR report key: 432679 · Received December 12, 2002

    Report

    Report Number
    432679
    Event Type
    Injury
    Date Received
    December 12, 2002
    Date of Event
    May 3, 2002
    Report Date
    November 6, 2002
    Manufacturer
    BIOMET ORTHOPEDICS, INC
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2002, TOTAL KNEE REPLACEMENT (TKA). THIS HEALED WELL BUT THEIR EXTENSOR MECHANISM WAS NOT WORKING. FIVE WEEKS LATER, REVISION OF TKA DUE TO FAILED EXTENSOR MECHANISM. ELEVEN DAYS LATER, DEHISCENCE OF WOUND WITH EVIDENCE OF DEEP SPACE INFECTION TRACKING DOWN TO THE KNEE PROSTHESIS NECESSITATING REMOVAL OF THE TOTAL KNEE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC TOTAL KNEE COMPONENTS HSA BIOMET ORTHOPEDICS, INC * *
    2 BIOMET ORTHOPEDICS, INC TOTAL KNEE COMPONENTS HSA BIOMET ORTHOPEDICS, INC * *
    3 BIOMET ORTHOPEDICS, INC TOTAL KNEE COMPONENT HSA BIOMET ORTHOPEDICS INC * *
    4 BIOMET ORTHOPEDICS, INC TOTAL KNEE COMPONENT HSA BIOMET ORTHOPEDICS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention