BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1497242 · Received September 1, 2009

    Report

    Report Number
    9610726-2009-00177
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AND WAS CLEARED (B)(4). AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CEMENT WAS INJECTED INTO THE DISTAL FEMORAL CANAL AFTER MIXING FOR 40 SECONDS. HOWEVER, IT SET APPROXIMATELY WITHIN 3 MINUTES. THEREFORE, THE SURGEON STOPPED INJECTING THE CEMENT. SINCE NO OTHER CEMENT WAS AVAILABLE AT THIS HOSPITAL, ANOTHER WAS DELIVERED FROM A NEARBY HOSPITAL TAKING ABOUT 1 HOUR. THERE WAS NO PROBLEM WITH PATIENT'S BLOOD PRESSURE AND PULSE. TOTAL BLOOD LOSS WAS 600ML. THE CEMENT HAD BEEN STORED AT THE HOSPITAL AT 25C FOR 1 MONTH THEN STORED IN A REFRIGERATOR 1 DAY PRIOR TO THE SURGERY AND IT WAS TAKEN OUT 20 MINUTES PRIOR TO THE SURGERY. THE OPERATING ROOM TEMPERATURE WAS AT 20C. NO ANTIBIOTIC WAS MIXED WITH THE CEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other