BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 375665 · Received January 30, 2002

    Report

    Report Number
    375665
    Event Type
    Injury
    Date Received
    January 30, 2002
    Date of Event
    January 1, 2001
    Report Date
    January 23, 2002
    Manufacturer
    BIOMET
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1. PAIN, 2. DECREASED FUNCTIONAL CAPABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MALLORY/HEAD MODULAR CALCAR JDI BIOMET DISTAL BOWED STEM 19 X 300 60% 22947
    2 BIOMET MALLORY/HEAD MODULAR CALCAR JDI BIOMET PROXIMAL FEM REPLACEMENT 621690

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention