BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 50G

    MDR report key: 9574628 · Received January 10, 2020

    Report

    Report Number
    1818910-2020-01418
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 19, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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.  H10 ADDITIONAL NARRATIVE:  ADDED B5, H6. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE SURGERY PROLONGED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY :THE COMPLAINT STATES: ¿IT WAS REPORTED THAT CEMENT (P / N: 3172050) SUDDENLY STARTED TO HARDEN AT PAST 5 MINUTES AFTER MIXING DURING TKA SURGERY ON (B)(6), 2019. THE SURGEON REMOVED THE CEMENT IN QUESTION FROM FEMUR BEFORE THE CEMENT WAS HARDEN AND COULD AVOIDING HARDEN DURING IMPLANTATION. THE SURGERY WAS COMPLETED IN 10 MINUTES OR MORE AND LESS THAN 30 MINUTES BY USING A NEW CEMENT. DOCTORS COMMENTS: THE DOCTOR JUDGED THAT CEMENT WAS DEFECTIVE. POSSIBLE CAUSE: INSUFFICIENT MIXING OF CEMENT OR INSUFFICIENT TEMPERATURE CONTROL. NO FURTHER INFORMATION IS AVAILABLE.¿ THE HOSPITAL DID NOT RETURN A SAMPLE OF THE LOT NUMBER FOR TESTING. RETAINED SAMPLES WERE RETRIEVED AND TESTED TO TM-T150 AND TM-T228 (SEE ATTACHMENT (B)(4). RETEST RESULTS.PDF). TM-T150 CEMENT RESULTS: EXTRUDED @ 2MIN 15SEC. END OF WORKING TIME: 08MIN 67SEC. SETTING TIME: 11MIN 32SEC. THE CEMENT MIXED AND BEHAVED AS EXPECTED; ALL RESULTS ARE WITHIN SPECIFICATION. TM-T228 FUNCTIONAL TESTING . ALL OBSERVATIONS PASSED, INCLUDING EFFECTIVE VACUUM DURING MIXING, AND THE CEMENT MIXED AND EXTRUDED EASILY. THE COMPLAINT DESCRIPTION CANNOT BE CONFIRMED BASED ON THESE RESULTS. DVA-104409-FDE REV 10 WAS REVIEWED, AND THIS POSSIBLE FAILURE MODE IS INCLUDED ON LINE 471 (SEE ATTACHMENT (B)(4). EXTRACT FROM DVA-104409-FDE.PDF). THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. THE IFU FOR THIS PRODUCT WAS CHECKED, AND IT INCLUDES THE FOLLOWING STATEMENTS: ¿BONE CEMENTS ARE HEAT SENSITIVE. ANY INCREASE OR DECREASE IN TEMPERATURE (EITHER AMBIENT, AND/ OR OF THE CEMENT COMPONENTS AND MIXING EQUIPMENT) FROM THE RECOMMENDED TEMPERATURE OF 23°C WILL AFFECT THE HANDLING CHARACTERISTICS AND SETTING TIME OF THE CEMENT. IN ADDITION, VARIATIONS IN HUMIDITY WILL AFFECT THE HANDLING CHARACTERISTICS AND SETTING TIME¿. ¿UNDER CONTROLLED LABORATORY CONDITIONS, THE FINAL HARDENING TIME IS 11-13 MINUTES FROM THE START OF MIXING. THE FINAL HARDENING TIME OF THE CEMENT IS HOWEVER INFLUENCED BY THE CLINICAL PROCEDURE AND THEATRE CONDITIONS. IN PARTICULAR, BODY TEMPERATURE WILL REDUCE THE FINAL SETTING TIME.¿ THE CEMENT CHECKLIST ISSUE TO THE HOSPITAL WAS NOT COMPLETED WITH THE STORAGE INFORMATION. THE COMPLAINT DESCRIPTION SUGGESTS THAT THE CEMENT WAS NOT MIXED ADEQUATELY AND/ OR THAT THE STORAGE CONDITIONS DID NOT MEET THE TEMPERATURE REQUIREMENTS. 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 SAMPLE. HOWEVER, THE CONDITIONING AND STORAGE OF THE PRODUCT, OR THE OPERATING THEATRE TEMPERATURE COULD HAVE POTENTIALLY AIDED THE UNUSUAL BEHAVIOUR DESCRIBED. 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: 2 UNRELATED NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. 678 UNITS RELEASED. LOT EXPIRY DATE: 31-MAY-21.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGICAL DELAY WAS IN 10 MINUTES OR MORE AND LESS THAN 30 MINUTES AS WE REGISTERED IN THE EVENT DESCRIPTION INITIALLY.

    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

    IT WAS REPORTED THAT CEMENT (P/N: 3172050) SUDDENLY STARTED TO HARDEN AT PAST 5 MINUTES AFTER MIXING DURING TKA SURGERY ON (B)(6) 2019. THE SURGEON REMOVED THE CEMENT IN QUESTION FROM FEMUR BEFORE THE CEMENT WAS HARDEN AND COULD AVOIDING HARDEN DURING IMPLANTATION. THE SURGERY WAS COMPLETED IN 10 MINUTES OR MORE AND LESS THAN 30 MINUTES BY USING A NEW CEMENT. DOCTORS COMMENTS: THE DOCTOR JUDGED THAT CEMENT WAS DEFECTIVE. POSSIBLE CAUSE: INSUFFICIENT MIXING OF CEMENT OR INSUFFICIENT TEMPERATURE CONTROL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41511 VMP ENDURANCE 50G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9174148

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR