BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 370619 · Received January 10, 2002

    Report

    Report Number
    370619
    Event Type
    Injury
    Date Received
    January 10, 2002
    Date of Event
    December 13, 2001
    Report Date
    December 13, 2001
    Manufacturer
    BIOMET
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH PAIN. BROKEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMODULAR SHOULDER KWT BIOMET HUMERAL HEAD 166416
    2 BIOMET BIOMODULAR SHOULDER GLENOID-METAL BACK KWT BIOMET GLENOID-METAL BACK 937050
    3 BIOMET BIOMODULAR SHOULDER SCREWS KWT BIOMET SCREWS NO #'S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention