BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P TWIN PACK

    MDR report key: 1112509 · Received August 7, 2008

    Report

    Report Number
    9610726-2008-00049
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    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

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY, THE CEMENT SET TOO QUICKLY. IT SET IN 6 TO 7 MINUTES ALTHOUGH USUALLY 11 TO 12 MINUTES. THE SURGEON IS VERY EXPERIENCED WITH THE SIMPLEX CEMENT AND HE ADDRESSED THAT HE KEPT AND HANDLED THE CEMENT AS USUAL, HOWEVER, IT SET TOO QUICKLY. OPERATING ROOM TEMPERATURE WAS AT 24C. DISTRIBUTOR'S WAREHOUSE TEMPERATURE WAS 25C DURING THE DAY, HOWEVER, THE AIR CONDITIONER WAS OFF DURING NIGHTS. NIGHT IS AROUND 30C OR HIGHER, HOWEVER, IT GETS VERY WARM DURING SUMMER TIME. THE CEMENT WAS BROUGHT TO THE HOSP THE DAY BEFORE THE SURGERY AND KEPT IN A REFRIGERATOR UNTIL 10 MINUTES BEFORE THE SURGERY. THE MIXING WAS DONE MANUALLY. NO ANTIBIOTIC WAS MIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA JDP018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other