BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P SPEEDSET FULL DOSE 1 PACK

    MDR report key: 4935600 · Received July 23, 2015

    Report

    Report Number
    0002249697-2015-02418
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    PMA / PMN Number
    K063857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: 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. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW: BMR REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: 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 SIMPLEX BONE CEMENTS ARE INFLUENCED PRIMARILY BY THE TEMPERATURE OF THE LIQUID AND POWDER COMPONENTS AT THE TIME OF MIXING AND BY THE TEMPERATURES OF THE UTENSILS WITH WHICH IT CONTACTS DURING MIXING E.G. MIXING BOWLS, CEMENT INTRODUCERS ETC. GENERALLY, HIGHER TEMPERATURES ACCELERATE THE POLYMERIZATION REACTION AND LOWER TEMPERATURES DELAY IT. OTHER FACTORS WHICH CAN AFFECT SETTING TIME ARE MIXING TECHNIQUE (SPEED, USE OF VACUUM, CENTRIFUGATION), THOROUGHNESS OF MIXING, COMPLETE UTILIZATION OF ALL OF THE POWDER & LIQUID AND CARE TO AVOID INCLUSION OF ANY EXTRANEOUS MATERIAL SUCH AS BLOOD OR STERILIZATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. BASED ON THE LABORATORY RESULTS OF THE RETAIN SAMPLES IT IS NOT POSSIBLE TO REPLICATE THIS EVENT. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED THAT SIMPLEX SETTING TIME ISSUES MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE PRODUCT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL CALLED THE SALES REP AND ADVISED THAT CEMENT SET UP IN 6 MINUTES AFTER THEY HAD MIXED IT. FEMUR AND TIBIA WERE IMPLANTED BUT HAD TO MIX ANOTHER BATCH FOR PATELLA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL CALLED THE SALES REP AND ADVISED THAT CEMENT SET UP IN 6 MINUTES AFTER THEY HAD MIXED IT. FEMUR AND TIBIA WERE IMPLANTED BUT HAD TO MIX ANOTHER BATCH FOR PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481448 SIMPLEX P SPEEDSET FULL DOSE 1 PACK IMPLANT MBB STRYKER ORTHOPAEDICS-MAHWAH DBW006

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other