BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P WITH TOBRAMYCIN 1 PACK

    MDR report key: 3252806 · Received July 29, 2013

    Report

    Report Number
    0002249697-2013-02476
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THREE RETAIN SAMPLES OF THIS LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. THE EVENT WAS NOT CONFIRMED. DHR FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. CHR REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE REFERENCED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETAIN SAMPLES OF THE REPORTED LOT CODE MAU009 WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. THE MIXING CHARACTERISTICS AND WORKING PROPERTIES OF SURGICAL SIMPLEX BONE CEMENTS ARE INFLUENCED PRIMARILY BY THE TEMPERATURE OF THE PRODUCT AT THE TIME OF MIXING AND BY THE TEMPERATURES OF THE UTENSILS WITH WHICH IT CONTACTS DURING MIXING. IT IS IMPORTANT TO NOTE THAT FOR 12-24 HOURS PRIOR TO USE IN SURGERY, THE PRODUCT COMPONENTS SHOULD BE KEPT AT AMBIENT OR TEMPERATURE. ANOTHER KEY FACTOR IS THAT VIGOROUS MIXING MAY ACCELERATE THE POLYMERIZATION OF THE CEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR FELT THAT CEMENT WAS TAKING ENTIRELY TOO LONG TO HARDEN. HE WAS NOT SURE IF IT WAS THE ROOM CONDITIONS OR IF THERE WAS SOMETHING WRONG WITH THE CEMENT. THEY MADE THE ROOM WARMER, AND THE CEMENT DID GET HARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR FELT THAT CEMENT WAS TAKING ENTIRELY TOO LONG TO HARDEN. HE WAS NOT SURE IF IT WAS THE ROOM CONDITIONS OR IF THERE WAS SOMETHING WRONG WITH THE CEMENT. THEY MADE THE ROOM WARMER, AND THE CEMENT DID GET HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353156 SIMPLEX P WITH TOBRAMYCIN 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MAU009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other