BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 3033614 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01185
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 & 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 RJT161 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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL CALLED SALES REP AND ADVISED THAT THE SIMPLEX USED IN CASE WOULD NOT HARDEN PROPERLY. THE CEMENT WAS SUPER STICKY AND STICKING TO THE DOCTOR GLOVES. THEY PROCEEDED TO OPEN ANOTHER BOX AND WOULD NOT HARDEN PROPERLY. IMPLANTED GLENOID PROSTHESIS INTO PATIENT AND CAME OUT. USED ANOTHER BOX AND IT SET AND WORKED CORRECTLY. FIRST AND SECOND BOX DIDN'T WORK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL CALLED SALES REP AND ADVISED THAT THE SIMPLEX USED IN CASE WOULD NOT HARDEN PROPERLY. THE CEMENT WAS SUPER STICKY AND STICKING TO THE DOCTOR GLOVES. THEY PROCEEDED TO OPEN ANOTHER BOX AND WOULD NOT HARDEN PROPERLY. IMPLANTED GLENOID PROSTHESIS INTO PATIENT AND CAME OUT. USED ANOTHER BOX AND IT SET AND WORKED CORRECTLY. FIRST AND SECOND BOX DIDN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136048 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH RJT161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other