BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER TRAUMA GMBH - GAMMA3 SYSTEM

    MDR report key: 4935059 · Received June 15, 2015

    Report

    Report Number
    4935059
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 15, 2015
    Manufacturer
    STRYKER
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY PATIENT SUFFERED A HIP FRACTURE AFTER A FALL AT HOME. THE PATIENT UNDERWENT SURGERY FOR A HIP REPLACEMENT WITH STRYKER HARDWARE. SIX MONTHS LATER, THE PATIENT EXPERIENCED INCREASING HIP PAIN FOR TWO DAYS. AN X-RAY WAS PERFORMED TO SHOW THAT THE HARDWARE BROKE AND SURGICAL REPAIR WAS NEEDED. STRYKER HARDWARE WAS REMOVED AND ZIMMER HARDWARE WAS IMPLANTED. FOUR MONTHS LATER, THE HARDWARE BROKE AGAIN WHILE THE PATIENT STOOD UP FROM HER TABLE AT HOME. SHE EXPERIENCED PAIN AND WAS UNABLE TO BEAR WEIGHT. AGAIN, SURGICAL REPAIR WAS NEEDED. ZIMMER HARDWARE WAS REMOVED AND REPLACED BY ZIMMER VERSYS HIP SYSTEM. THE LAST SURGERY REQUIRED HEMO-VAC DRAINS TO BE PUT IN PLACE. THE DRAINAGE APPROPRIATELY DECREASED AFTER A FEW DAYS. THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY FOR REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388672 STRYKER TRAUMA GMBH - GAMMA3 SYSTEM STYKER LONG NAIL KIT HSB STRYKER * K919967
    388673 ZIMMER NATURAL NAIL ZIMMER CEPHALOMEDULLARY FEMORAL NAIL HSB STRYKER * 2767945

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R CARDIAC DRUGS