BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-ANGULAR/BI-POLAR MOD HEAD 22.2

    MDR report key: 509599 · Received February 2, 2004

    Report

    Report Number
    1825034-2004-00011
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    December 9, 2003
    Report Date
    January 20, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    MJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED IN 2003. DUE TO PAIN, REVISION PROCEDURE REPLACING BI-POLAR, LINER AND MODULAR HEAD WAS PERFORMED 10 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-ANGULAR/BI-POLAR MOD HEAD 22.2 PROSTHESIS, SHOULDER, COMP. MJT BIOMET, INC. NA 582510

    Patients

    Seq Age Sex Outcome Treatment
    1 *