BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 40G

    MDR report key: 7923821 · Received October 1, 2018

    Report

    Report Number
    1818910-2018-70960
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    April 23, 2018
    Report Date
    September 13, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY THE COMPLAINT STATES ¿2X CEMENT SAME LOT NUMBER 861649 WENT OFF IN 4MIN NO DELAY TO SURGERY. ROOM TEMP AND STORAGE TEMP NORMAL.¿ THE LOT NUMBER SUPPLIED IS INCORRECT AND SHOULD BE 8616349. RETAINED SAMPLES OF THE LOT WERE RETRIEVED FROM RETAINED STORAGE FOR CONDITIONING PRIOR TO TESTING FOR DOUGH AND SETTING TIMES. RETAINED POWDER AND LIQUID SAMPLES OF THE COMPLAINT BATCH IN QUESTION WERE OBTAINED, CONDITIONED TO 23°C, AND MIXED IN THE LABORATORY IN A BEAKER UNDER VENTILATED, TEMPERATURE AND HUMIDITY-CONTROLLED CONDITIONS. THE MIX WAS DRY WITH THE POWDER AND LIQUID COMPONENTS COMBINING TOGETHER AS NORMAL WITH A DOUGH TIME OF 34 SECONDS WHICH IS WITHIN THE SPECIFICATION LIMITS. THE SETTING TIME WAS ALSO WITHIN SPECIFICATION AT 4M 09S. THE APPEARANCE AND HANDLING CHARACTERISTICS OF THE CEMENT WERE AS EXPECTED WITH ALL RESULTS OBTAINED BEING WITHIN SPECIFICATION CRITERIA. THE CEMENT DID NOT APPEAR TO BE OVERLY VISCOUS AND ON TESTING, THE CEMENT APPEARED TO HAVE SLIGHT FLOW WHICH IS CHARACTERISTIC OF THIS CEMENT TYPE. NO PRODUCT PROBLEM OR UNUSUAL OBSERVATIONS WERE OBSERVED ON THE TESTING OF THE RETAINED SAMPLES OF THIS BATCH. DVA--(B)(4)-FDE REV 6 WAS REVIEWED, AND THIS ISSUE IS INCLUDED ON LINES 61-63, 66, 72-75 AND 176. FROM DVA-(B)(4)-FDE REV 6.PDF¿. IFU-06300004 REV B INCLUDES A PRECAUTION THAT ¿THE SETTING TIME OF THE CEMENT CAN BE REDUCED IF A VACUUM MIXING SYSTEM IS USED. THE SURGEON SHOULD READ THE MANUFACTURER¿S INSTRUCTIONS AND BE FAMILIAR WITH THE MIXING SYSTEM TOGETHER WITH THE CEMENT PRIOR TO USE.¿ IN THIS CASE A COMPETITOR MIXING SYSTEM WAS USED AND IT IS NOT POSSIBLE TO COMMENT ON THE SETTING TIME IN THAT SYSTEM. A ROOT CAUSE CANNOT BE DETERMINED AS THE COMPLAINT PROBLEM HAS NOT BEEN POSSIBLE TO REPLICATE WITH THE TESTING OF THE RETAINED SAMPLE. HOWEVER, THE CONDITIONING AND STORAGE OF THE PRODUCT, THE METHOD USED IN THE COMPETITOR MIXING SYSTEM, OR THE OPERATING THEATRE TEMPERATURE COULD HAVE POTENTIALLY AIDED THE UNUSUAL BEHAVIOUR MENTIONED. THE MIXING AND USE OF BONE CEMENT CAN BE SIGNIFICANTLY AFFECTED BY EXPOSURE TO HIGH OR LOW TEMPERATURES UP TO 24 HOURS BEFORE USE. THIS CAN CAUSE WIDE FLUCTUATIONS IN WORKING AND SETTING TIME. THE OPTIMUM TEMPERATURE FOR BONE CEMENT IS 23 DEGREES CELSIUS AS PER THE IFU. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT STATES ¿2X CEMENT SAME LOT NUMBER 861649 WENT OFF IN 4MIN NO DELAY TO SURGERY. ROOM TEMP AND STORAGE TEMP NORMAL.¿ THE LOT NUMBER SUPPLIED IS INCORRECT AND SHOULD BE 8616349. RETAINED SAMPLES OF THE LOT WERE RETRIEVED FROM RETAINED STORAGE FOR CONDITIONING PRIOR TO TESTING FOR DOUGH AND SETTING TIMES. RETAINED POWDER AND LIQUID SAMPLES OF THE COMPLAINT BATCH IN QUESTION WERE OBTAINED, CONDITIONED TO 23°C, AND MIXED IN THE LABORATORY IN A BEAKER UNDER VENTILATED, TEMPERATURE AND HUMIDITY-CONTROLLED CONDITIONS. THE MIX WAS DRY WITH THE POWDER AND LIQUID COMPONENTS COMBINING TOGETHER AS NORMAL WITH A DOUGH TIME OF 34 SECONDS WHICH IS WITHIN THE SPECIFICATION LIMITS. THE SETTING TIME WAS ALSO WITHIN SPECIFICATION AT 4M 09S. THE APPEARANCE AND HANDLING CHARACTERISTICS OF THE CEMENT WERE AS EXPECTED WITH ALL RESULTS OBTAINED BEING WITHIN SPECIFICATION CRITERIA. THE CEMENT DID NOT APPEAR TO BE OVERLY VISCOUS AND ON TESTING, THE CEMENT APPEARED TO HAVE SLIGHT FLOW WHICH IS CHARACTERISTIC OF THIS CEMENT TYPE. NO PRODUCT PROBLEM OR UNUSUAL OBSERVATIONS WERE OBSERVED ON THE TESTING OF THE RETAINED SAMPLES OF THIS BATCH. DVA--107020-FDE REV 6 WAS REVIEWED, AND THIS ISSUE IS INCLUDED ON LINES 61-63, 66, 72-75 AND 176. IFU-06300004 REV B INCLUDES A PRECAUTION THAT ¿THE SETTING TIME OF THE CEMENT CAN BE REDUCED IF A VACUUM MIXING SYSTEM IS USED. THE SURGEON SHOULD READ THE MANUFACTURER¿S INSTRUCTIONS AND BE FAMILIAR WITH THE MIXING SYSTEM TOGETHER WITH THE CEMENT PRIOR TO USE.¿ IN THIS CASE A COMPETITOR MIXING SYSTEM WAS USED AND IT IS NOT POSSIBLE TO COMMENT ON THE SETTING TIME IN THAT SYSTEM. A ROOT CAUSE CANNOT BE DETERMINED AS THE COMPLAINT PROBLEM HAS NOT BEEN POSSIBLE TO REPLICATE WITH THE TESTING OF THE RETAINED SAMPLE. HOWEVER, THE CONDITIONING AND STORAGE OF THE PRODUCT, THE METHOD USED IN THE COMPETITOR MIXING SYSTEM, OR THE OPERATING THEATRE TEMPERATURE COULD HAVE POTENTIALLY AIDED THE UNUSUAL BEHAVIOUR MENTIONED. THE MIXING AND USE OF BONE CEMENT CAN BE SIGNIFICANTLY AFFECTED BY EXPOSURE TO HIGH OR LOW TEMPERATURES UP TO 24 HOURS BEFORE USE. THIS CAN CAUSE WIDE FLUCTUATIONS IN WORKING AND SETTING TIME. THE OPTIMUM TEMPERATURE FOR BONE CEMENT IS 23 DEGREES CELSIUS AS PER THE IFU. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TWOX CEMENT WENT OFF IN 4 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763804 DEPUY CMW 2G 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1