BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 4130397 · Received September 30, 2014

    Report

    Report Number
    0002249697-2014-03689
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. DEVICES NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE AND EXPIRATION DATE CORRECTED. AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THREE RETAIN SAMPLES OF THE REPORTED LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. NO MEDICAL RECORDS WERE RECEIVED OR WERE RELEVANT TO THE INVESTIGATION OF THIS EVENT. DEVICE HISTORY REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO OTHER 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 WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE REOPENED. MANUFACTURING DATE AND EXPIRATION DATE CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FINAL SET TIME OF THE CEMENT WAS VERY SHORT DURING MEDICAL PROCEDURE. WORKING TIME WAS LONG. AT FIRST, THE CEMENT DID NOT HARDEN, AND THEN THE CEMENT HARDENED QUICKLY, BUT TOTAL SETTING TIME WAS 10 MIN. THE TEMP OF THE OPERATING ROOM WAS NOT SPECIFIED. THE CEMENT WAS STORED IN THE REFRIGERATOR, BUT WE COULD NOT SPECIFY HOW LONG AND THE TEMP WERE NOT SPECIFIED. REVOLUTION WAS USED AND IT WAS STORED IN GENERAL TEMP(SPECIFIC TEMP WAS NOT CLARIFIED.) ANTIBIOTIC AND ANY OTHER SUBSTANCE WERE NOT MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FINAL SET TIME OF THE CEMENT WAS VERY SHORT DURING MEDICAL PROCEDURE. WORKING TIME WAS LONG. AT FIRST, THE CEMENT DID NOT HARDEN, AND THEN THE CEMENT HARDENED QUICKLY, BUT TOTAL SETTING TIME WAS 10 MIN. THE TEMP OF THE OP ROOM WAS NOT SPECIFIED. THE CEMENT WAS STORED IN THE REFRIGERATOR, BUT WE COULD NOT SPECIFY HOW LONG AND THE TEMP WERE NOT SPECIFIED. REVOLUTION WAS USED AND IT WAS STORED IN GENERAL TEMP(SPECIFIC TEMP WAS NOT CLARIFIED.) ANTIBIOTIC AND ANY OTHER SUBSTANCE WERE NOT MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609248 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JDV015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other