BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3111742 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01668
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAIN SAMPLES OF THIS LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. THE MIXING CHARACTERISTICS AND WORKING PROPERTIES OF SURGICAL 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 POLYMERISATION 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 AND LIQUID AND CARE TO AVOID INCLUSION OF ANY EXTRANEOUS MATERIAL SUCH AS BLOOD OR STERILISATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. THE MIXING PROPERTIES OF THE RETAIN SAMPLES OF THE REPORTED LOT CODE JAU004 WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. IT WAS NOT POSSIBLE TO REPLICATE THIS EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT DID NOT HARDENED FOR 7 MIN AND 30 SEC AND CONTINUED TOO LOW VISCOSITY. AFTER THAT THE CEMENT HARDENED TOO QUICKLY. THE CEMENT WAS INSERTED WITH HIGHER VISCOSITY THAN USUAL AND THE SURGEON IMPLANTED EXETER WITH STRONG FORCE. ACCORDING TO THE X-RAY WHICH WAS TAKEN JUST AFTER THE OP, THE TIP OF THE EXETER BROKE LATERAL FEMUR. SO, REVISION SURGERY WILL BE PERFORMED. THE CEMENT IS USUALLY STORED IN GENERAL TEMP(NOT IN REFRIGERATOR) FOR ABOUT 2 MONTHS. OP ROOM TEMP WAS NOT SPECIFIED. NO SUBSTANCES SUCH AS BLOOD, SALINE WATER AND ANTIBIOTIC WERE MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED. REVOLUTION MIXING SYSTEM WAS USED AND IT IS ALSO STORED IN GENERAL TEMP USUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT DID NOT HARDENED FOR 7 MIN AND 30 SEC AND CONTINUED TOO LOW VISCOSITY. AFTER THAT THE CEMENT HARDENED TOO QUICKLY. THE CEMENT WAS INSERTED WITH HIGHER VISCOSITY THAN USUAL AND THE SURGEON IMPLANTED EXETER WITH STRONG FORCE. ACCORDING TO THE X-RAY WHICH WAS TAKEN JUST AFTER THE OP, THE TIP OF THE EXETER BROKE LATERAL FEMUR. SO, REVISION SURGERY WILL BE PERFORMED. THE CEMENT IS USUALLY STORED IN GENERAL TEMP (NOT IN REFRIGERATOR) FOR ABOUT 2 MONTHS. OP ROOM TEMP WAS NOT SPECIFIED. NO SUBSTANCES SUCH AS BLOOD, SALINE WATER AND ANTIBIOTIC WERE MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED. REVOLUTION MIXING SYSTEM WAS USED AND IT IS ALSO STORED IN GENERAL TEMP USUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212037 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JAU004

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other