BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ORTHOPEDICS, INC. REPICCI II

    MDR report key: 569287 · Received January 31, 2005

    Report

    Report Number
    569287
    Event Type
    Malfunction
    Date Received
    January 31, 2005
    Date of Event
    December 14, 2004
    Report Date
    December 27, 2004
    Manufacturer
    BIOMET ORTHOPEDICS, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LEFT KNEE UNICOMPARTMENTAL REPLACEMENT IN 2004. SINCE THEN, PERSISTENT PAIN. DIAGNOSIS OF FAILED / LOOSE UNICOMPARTMENTAL ARTHROPLASTY. ABOUT SIX MONTHS LATER, UNDERWENT LEFT UNICOMPARTMENTAL KNEE PROSTHESIS REMOVAL AND LEFT KNEE TOTAL ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC. REPICCI II KNEE-FEMORAL AND TIBIAL COMPONENTS JWH BIOMET ORTHOPEDICS, INC. FEMORAL 102101 TIBIA 102140
    2 BIOMET ORTHOPEDICS, INC. REPICCI II KNEE-FEMORAL & TIBIAL COMPONENTS HRY BIOMET ORTHOPEDICS, INC. FEMORAL 102101 TIBIA 102140

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other PALASCO BONE CEMENT, BATCH NUMBER 3219850.