BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 2G 40G

    MDR report key: 9370885 · Received November 25, 2019

    Report

    Report Number
    1818910-2019-117868
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 28, 2019
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT STATES: ¿HOSPITAL USED 4 SEPARATE MIXES OF DEPUY CMW 2 BONE CEMENT AND HAVE REPORTED THAT ALL 4 MIXES SET PREMATURELY. MICHELLE O'CONNOR FROM HOLLYWOOD PRIVATE HOSPITAL REPORTED THAT ALL 4 MIXES WERE MIXED SEPARATELY, ALL WERE MIXED IN A MIXING BOWL WITHOUT VACUUM AS PER SUPPLIER RECOMMENDATIONS, AND ALL 4 MIXES WERE STORED WITHIN THE THEATRE COMPLEX IN A CONTROLLED ENVIRONMENT AT 19 DEGREES CENTIGRADE.¿ THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY CONTROLLED LABORATORY (SEE ATTACHMENT ¿(B)(4) RETEST RESULTS.PDF¿). 9023931. MEAN DOUGH TIME: 0MIN 45SEC. MEAN SETTING TIME: 4MIN 42SEC. MIX CHARACTERISTICS: DRY. HANDLING CHARACTERISTICS: FIRM. 9039311. MEAN DOUGH TIME: 0MIN 43SEC. MEAN SETTING TIME: 4MIN 35SEC. MIX CHARACTERISTICS: DRY. HANDLING CHARACTERISTICS: FIRM. 9031514. MEAN DOUGH TIME: 0MIN 45SEC. MEAN SETTING TIME: 4MIN 45SEC. MIX CHARACTERISTICS: DRY. HANDLING CHARACTERISTICS: FIRM. THE REPORTED FAILURE WAS NOT REPEATED IN THE TESTING OF THE RETAINED SAMPLES OF THESE BATCHES. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE. THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED FROM THE RESULTS OF THIS TESTING. ROOT CAUSE CANNOT BE DETERMINED FROM THE RESULTS OF THIS TESTING. DVA-107020-FDE REV 9 WAS REVIEWED, AND THIS FAILURE MODE IS INCLUDED ON LINES 61, 62, 72, 73, 74, 75, AND 177. IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. THE MIXING AND USE OF BONE CEMENT CAN BE SIGNIFICANTLY AFFECTED BY EXPOSURE TO HIGH OR LOW TEMPERATURES UP TO 24 HOURS BEFORE USE. THE OPTIMUM TEMPERATURE FOR BONE CEMENT IS 23 DEGREES CELSIUS AS PER THE IFU. CONCLUSION AND FURTHER ACTION: A ROOT CAUSE CANNOT BE DETERMINED AS THE COMPLAINT PROBLEM HAS NOT BEEN POSSIBLE TO REPLICATE WITH THE TESTING OF THE RETAINED SAMPLES. HOWEVER, THE CONDITIONING AND STORAGE OF THE PRODUCT, OR THE OPERATING THEATRE TEMPERATURE COULD HAVE POTENTIALLY AIDED THE UNUSUAL BEHAVIOUR MENTIONED. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS REQUIRED. DEVICE HISTORY LOT : DEVICE HISTORY REVIEWED: 9031514 0 NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 31 DECEMBER 2021

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    HOSPITAL USED 4 SEPARATE MIXES OF DEPUY CMW 2 BONE CEMENT AND HAVE REPORTED THAT ALL 4 MIXES SET PREMATURELY. IT WAS REPORTED THAT ALL 4 MIXES WERE MIXED SEPARATELY, ALL WERE MIXED IN A MIXING BOWL WITHOUT VACUUM AS PER SUPPLIER RECOMMENDATIONS, AND ALL 4 MIXES WERE STORED WITHIN THE THEATRE COMPLEX IN A CONTROLLED ENVIRONMENT AT 19 DEGREES CENTIGRADE. IF OTHER, DESCRIBE: N/A. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168293 DEPUY CMW 2G 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9031514

    Patients

    Seq Age Sex Outcome Treatment
    1