BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 3559246 · Received January 7, 2014

    Report

    Report Number
    0002249697-2014-00083
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX BONE CEMENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAINED SAMPLES TESTED OF THE REPORTED LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED OR WERE RELEVANT TO THE INVESTIGATION OF THIS EVENT. 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 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 RETAINED SAMPLES OF THE REPORTED LOT CODE WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. 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 POLYMERIZATION REACTION AND LOWER TEMPERATURES DELAY IT.

    Description of Event or Problem · 1

    WHILE MIXING CEMENT WITHIN NORMAL CONDITIONS OF ROOM TEMPERATURE AND HUMIDITY, USING NORMAL TECHNIQUES THE CEMENT BEGAN TO HARDEN WITHIN ABOUT ONE MINUTE AFTER THE MIXING HAD BEGUN. THE FIRST 2 DOSES WERE DISCARDED, THEN THEY OPENED 2 MORE DOSES OF THE SAME LOT CODE, WITH THE SAME RESULTS THE CEMENT HARDENED WITH ONE MINUTE. THEN THEY TRIED TO MIX FOR A THIRD TIME WITH 2 MORE DOSES OF A DIFFERENT LOT CODE AND THE MIXING AND DELIVERY OF THE CEMENT INTO THE FEMUR FOR THE TOTAL HIP ARTHROPLASTY WAS SUCCESSFUL AND THE CEMENT PERFORMED WITHIN ITS NORMAL TIME FRAME.

    Description of Event or Problem · 1

    WHILE MIXING CEMENT WITHIN NORMAL CONDITIONS OF ROOM TEMPERATURE AND HUMIDITY, USING NORMAL TECHNIQUES THE CEMENT BEGAN TO HARDEN WITHIN ABOUT ONE MINUTE AFTER THE MIXING HAD BEGUN. THE FIRST 2 DOSES WERE DISCARDED, THEN THEY OPENED 2 MORE DOSES OF THE SAME LOT CODE, WITH THE SAME RESULTS THE CEMENT HARDENED WITH ONE MINUTE. THEN THEY TRIED TO MIX FOR A THIRD TIME WITH 2 MORE DOSES OF A DIFFERENT LOT CODE AND THE MIXING AND DELIVERY OF THE CEMENT INTO THE FEMUR FOR THE TOTAL HIP ARTHROPLASTY WAS SUCCESSFUL AND THE CEMENT PERFORMED WITHIN ITS NORMAL TIME FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9069 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH RGU112

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other