BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY

    MDR report key: 1220919 · Received November 4, 2008

    Report

    Report Number
    MW5008880
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BIOMET
    Product Code
    JDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD ELBOW ARTHROPLASTY PROCEDURE IN 2003. AROUND 2008, THE PT FELL AND X-RAYS SHOWED AN ULNA COMPONENT FRACTURE. PT ON THIRTEEN DAYS LATER, SHOWED DEVICE FAILURE AS THE DEVICE HAD BROKEN. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY ELBOW RIGHT ULNA JDC BIOMET 114812 787000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability