BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°

    MDR report key: 3932153 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00329
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT HIP DUE TO POST SURGICAL PAIN. THE LAG SCREW MIGRATED TO THE ACETABULUM. PATIENT WAS REVISED. ALL COMPONENTS WERE REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409415 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K487202

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention