BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM PREVISIONAL STEM

    MDR report key: 3831907 · Received March 6, 2014

    Report

    Report Number
    1822565-2014-00261
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 4, 2014
    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 TRIAL COMPONENTS BROKE WHILE TRYING TO REMOVE THEM FROM THE HUMERUS. THE DISTAL PILOT WAS STUCK. ALL PARTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134973 ZIMMER TM PREVISIONAL STEM HSD ZIMMER, INC. 60408791

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ZIMMER TM DISTAL PILOT, CATALOG# 00431201013,| LOT# 61603449