BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1062284 · Received June 17, 2008

    Report

    Report Number
    9610726-2008-00033
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, IT WAS FOUND THAT THE CEMENT SET TOO QUICKLY IN 5 MIN. A POWDER ANTIBIOTIC WAS MIXED WITH THE CEMENT. ANOTHER NEW CEMENT WAS USED WITHOUT PROBLEM. THE OPERATING ROOM TEMPERATURE WAS 23 DEGREE IN C. THE MIXING TIME WAS 1 MIN. THE CEMENT WAS KEPT IN ROOM TEMPERATURE BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS NA JAP003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other