BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM

    MDR report key: 3605206 · Received December 6, 2013

    Report

    Report Number
    1822565-2013-01759
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    October 18, 2013
    Report Date
    November 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 OTJ TAPER PROTECTOR WOULD NOT THREAD ONTO THE DISTAL TAPERED STEM. THE STEM HAD TO BE REMOVED AND ANOTHER STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633808 ZMR HIP SYSTEM FEMORAL STEM KWZ ZIMMER, INC. 62309846

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR ZMR HIP SYSTEM TAPER PROTECTOR:| CATALOG #00997500700, LOT #61046139