BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP MODULAR FLEX DRILL BIT

    MDR report key: 1791914 · Received August 4, 2010

    Report

    Report Number
    1822565-2010-00552
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DRILL BIT BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP MODULAR FLEX DRILL BIT HIP PROSTHESIS HTW ZIMMER, INC. 61510506

    Patients

    Seq Age Sex Outcome Treatment
    1