BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 443587 · Received February 20, 2003

    Report

    Report Number
    443587
    Event Type
    Malfunction
    Date Received
    February 20, 2003
    Date of Event
    January 6, 2003
    Report Date
    February 3, 2003
    Manufacturer
    BIOMET INC
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SUREGERY TO REPAIR FAILED RIGHT TOTAL HIP REPLACEMENT WITH A FRACTURED MODULAR CALCAR MALLORY HERD STEM WITH FAILED ACETABULUM "COLLI".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET M/H MODULAR DISTAL BOWED STEM 80% 15 X 250MM JDI BIOMET INC * 108275 L/N 614360
    2 BIOMET M/H MODULAR CALCAR PROXIMAL 34MM C JDI BIOMET, INC * 108115 L/N 942960

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other