BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 2450149 · Received February 9, 2012

    Report

    Report Number
    MW5024193
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE INJECTING CEMENT DOWN THE FEMORAL CANAL, THE TIP OF THE STRYKER INJECTOR RAISED FROM THE TOP OF THE INJECTOR ALLOWING CEMENT TO RISE/SPILL FROM TOP THUS PREVENTING THE CEMENT TO FULLY DEPLOY INTO CANAL SPACE. THE SMALL AMOUNT OF CEMENT THAT DID GET INTO THE CANAL SPACE HARDENED THUS THE NEED TO REMOVE ALL CEMENT FROM CANAL. FINAL PLACEMENT OF A CEMENTED PROSTHESIS WAS THEN CARRIED OUT. POST OP RADIOGRAPH REVEALED A SMALL HOLE IN FEMUR WITH SOME EXTRUDED CEMENT. PATIENT SUBSEQUENTLY RETURNED TO OPERATING ROOM TO REPAIR DEFECT AND REMOVE EXTRUDED CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER MIXING SYSTEM W/FEMORAL BREAKAWAY NOZZEL JDZ STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention