BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYN SEL II CEM SO 10/12 SZ16

    MDR report key: 1466419 · Received September 8, 2009

    Report

    Report Number
    1020279-2009-00682
    Event Type
    Death
    Date Received
    September 8, 2009
    Date of Event
    August 8, 2009
    Report Date
    September 8, 2009
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONDITION WAS DETERIORATED SUDDENLY AND LEAD TO DEATH AFTER THE DOCTOR INJECTED AN INTRAMEDULLARY CEMENT, WHICH WAS MADE BY STRYKER (NAME: SIMPLEX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYN SEL II CEM SO 10/12 SZ16 FEMORAL STEM / JDH JDH BROOKS MANUFACTURING SITE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death