BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1113309 · Received August 12, 2008

    Report

    Report Number
    9610726-2008-00050
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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. DISTRIBUTORS' WAREHOUSE TEMPERATURE WAS 25C DURING THE DAY. HOWEVER, THE AIR CONDITIONER WAS OFF DURING NIGHTS. THE TEMPERATURE AT NIGHT IS UNK EXACTLY; HOWEVER, IT GETS VERY WARM DURING SUMMER TIME (AROUND 30 C OR HIGHER). THE MIXING WAS DONE MANUALLY. NO ANTIBIOTIC WAS MIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA JEP019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other