BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 4943239 · Received July 27, 2015

    Report

    Report Number
    0002249697-2015-02453
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY THE HOSPITAL 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

    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: CHR REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR EVENTS REPORTED FOR THE REFERENCED LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT WAS HARDENED QUICKLY. THE SURGEON NOTICED THAT IT WAS HARD TO INSERT THE CEMENT WITH THE GUN MIN FROM STARTING TO MIX THE CEMENT. THE CEMENT WAS HARDENED COMPLETELY FOR ONLY 6 MIN. SO, THE EXETER COULD NOT BE INSERTED COMPLETELY IN THE CANAL. THE SURGEON MIXED THE CEMENT AGAIN. THE PROCEDURE WAS COMPLETED WITH 4 HOURS DELAY AND FEMUR WAS BROKEN FOR REPLACEMENT OF THE STEM AND CEMENT. CABLE WAS USED FOR FIX THE BROKEN FEMUR. NEW STEM, REVOLUTION AND CEMENT WERE USED. THE TEMP OF THE OP ROOM WAS 19C. THE CEMENT WAS STORED IN THE REFRIGERATOR FOR 2 DAYS. IT WAS GOT OUT FROM THE REFRIGERATOR(4 DEGREES) 5 MIN BEFORE MIXING. THE REVOLUTION MIXING SYSTEM WAS STORED IN THE 19 DEGREES ROOM FOR 20 DAYS. 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 CEMENT WAS HARDENED QUICKLY. THE SURGEON NOTICED THAT IT WAS HARD TO INSERT THE CEMENT WITH THE GUN MIN FROM STARTING TO MIX THE CEMENT. THE CEMENT WAS HARDENED COMPLETELY FOR ONLY 6 MIN. SO, THE EXETER COULD NOT BE INSERTED COMPLETELY IN THE CANAL. THE SURGEON MIXED THE CEMENT AGAIN. THE PROCEDURE WAS COMPLETED WITH 4 HOURS DELAY AND FEMUR WAS BROKEN FOR REPLACEMENT OF THE STEM AND CEMENT. CABLE WAS USED FOR FIX THE BROKEN FEMUR. NEW STEM, REVOLUTION AND CEMENT WERE USED. THE TEMP OF THE OP ROOM WAS 19C. THE CEMENT WAS STORED IN THE REFRIGERATOR FOR 2 DAYS. IT WAS GOT OUT FROM THE REFRIGERATOR(4 DEGREES) 5 MIN BEFORE MIXING. THE REVOLUTION MIXING SYSTEM WAS STORED IN THE 19 DEGREES ROOM FOR 20 DAYS. 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
    486888 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JDW011

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention