BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA3

    MDR report key: 2152915 · Received June 29, 2011

    Report

    Report Number
    2152915
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER CORP
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A BISPHOSPHONATE-INDUCED STRESS FRACTURE OF HIP (SUBTROCHANTERIC) AND UNDERWENT GAMMA NAIL SURGERY. PT. FAILED TO HEAL AFTER 10 MONTHS. NONUNION OF SUBTROCHANTERIC FRACTURE WAS CONFIRMED ON CT. THE DISTAL SCREW WAS BROKEN. PATIENT SUSEQUENTLY RETURNED TO SURGERY TO EXCHANGE GAMMA NAIL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA3 LOCKING SCREW FOR GAMMA NAIL HSB STRYKER CORP 1896-5045S K264615

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R OTHER