BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER SIMPLEX BONE CEMENT

    MDR report key: 633125 · Received August 23, 2005

    Report

    Report Number
    633125
    Event Type
    Other
    Date Received
    August 23, 2005
    Date of Event
    July 5, 2005
    Report Date
    August 23, 2005
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS IN SURGERY FOR REPAIR OF A HIP FRACTURE. TWO BOXES OF SIMPLEX CEMENT WERE MIXED AS DIRECTED; HOWEVER, THEY DID NOT FILL THE SYRINGE WITH THE USUAL AMOUNT OF CEMENT. X-RAYS WERE TAKEN TO ASSURE PLACEMENT OF COMPONENT AND FOLLOW-UP X-RAY DISPLAYED PROPER ALIGNMENT WITHOUT LOOSENING OF COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SIMPLEX BONE CEMENT BONE CEMENT LOD STRYKER HOWMEDICA OSTEONICS, INC. CONTROL RCMO75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR