BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM HUMERAL STEM INSERTER

    MDR report key: 3201631 · Received June 26, 2013

    Report

    Report Number
    1822565-2013-01027
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON ATTACHED THE INSTRUMENT TO THE STEM TRIAL TO REMOVE THE TRIAL FROM THE PATIENT'S HUMERAL CANAL. UPON TRYING TO SLAP-HAMMER OUT THE TRIAL, THE DEVICE KEPT DISCONNECTING FROM THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290056 ZIMMER TM HUMERAL STEM INSERTER HSD ZIMMER, INC. 61714740

    Patients

    Seq Age Sex Outcome Treatment
    1