BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3171360 · Received June 14, 2013

    Report

    Report Number
    0002249697-2013-01926
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED LOT. A VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAIN SAMPLES OF THIS LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETAIN SAMPLES OF THE REPORTED LOT CODE 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 THE CEMENT STARTED TO BE HARDENED FOR 2 MIN AND IT HARDENED COMPLETELY FOR ONLY 6MIN STARTING FROM MIXING WITH ACM IN BHA WITH E.O.N. 2 VIALS OF THE ANTIBIOTIC (200ML,AMILACIN) WERE MIXED INTO THE CEMENT. THE SURGEON USED ANOTHER CEMENT WITH MIX KIT INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND DELAY. ALL MONOMER AND POLYMER WERE USED. THE TEMPERATURE OF THE OP ROOM AND STORE ROOM WERE BOTHE 24C. TWO PACS OF THE CEMENTS WERE USED. WE CANNOT SPECIFY THAT HOW THE ACM WAS STORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT STARTED TO BE HARDENED FOR 2 MIN AND IT HARDENED COMPLETELY FOR ONLY 6MIN STARTING FROM MIXING WITH ACM IN BHA WITH E.O.N. 2 VIALS OF THE ANTIBIOTIC (200ML,AMILACIN) WERE MIXED INTO THE CEMENT. THE SURGEON USED ANOTHER CEMENT WITH MIX KIT INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND DELAY. ALL MONOMER AND POLYMER WERE USED. THE TEMPERATURE OF THE OP ROOM AND STORE ROOM WERE BOTHE 24C. TWO PACS OF THE CEMENT WERE USED. WE CANNOT SPECIFY THAT HOW THE ACM WAS STORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271932 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JKT039

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other