BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 159316 · Received March 25, 1998

    Report

    Report Number
    159316
    Event Type
    Injury
    Date Received
    March 25, 1998
    Date of Event
    March 10, 1998
    Report Date
    March 13, 1998
    Manufacturer
    STRYKER MEDICAL INSTRUMENTS
    Product Code
    JDZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ROD FROM CEMENT GUN INJECTOR WAS INJECTED INTO THE LEFT FEMORAL CANAL BEFORE PROSTHESIS INSERTED. POST OP XRAY SHOWED DISTAL STEM PERFORATED POSTERIORLY. PLAN TO RETURN TO SURGERY IN 7-10 DAYS FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS HIGH VACUUM MIXING BOWL WITH FEMORAL NOZZLE JDZ STRYKER MEDICAL INSTRUMENTS 206-563 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R| S