BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 18777959 · Received February 26, 2024

    Report

    Report Number
    1818910-2024-04306
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 20, 2024
    Report Date
    February 26, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    HTQ
    PMA / PMN Number
    OUS - SIMILA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. LOT: 4047321 MANUFACTURING DATE: 02 FEB 23 EXPIRY DATE: 31 JAN 25 QUANTITY: (B)(4). PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE - 3172080, LOT NUMBER - 4047321, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY LOT: 4047321 EXTRUDE TIME: 2 MIN 15S. MIX CHARACTERISTICS: OK SETTING TIME: 10 MIN 35S (SPEC: 10 MIN 00S TO 14 MIN 30S). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (REF: MS-022 MASTER SPECIFICATION FOR VACUMIX PLUS ENDURANCE BONE CEMENT). AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE - 3172080, LOT NUMBER - 4047321, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). G4: NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT THE SAME/SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTIFICIAL ELBOW JOINT REPLACEMENT SURGERY PERFORMED ON (B)(6) 2024. WHEN THE SURGEON ATTEMPTED TO PUT LIQUID INTO POWDER THROUGH A FUNNEL, THE LIQUID DID NOT ENTER THE BOTTLE THROUGH THE FUNNEL AND WAS STUCK IN THE BOTTLE. THE FUNNEL WAS FULL OF LIQUID AND THEN SLOWLY DROP BY DROP INTO THE BOTTLE. HOWEVER, IT WAS NOT IN A CONDITION TO BE USED FOR SURGERY. A SPARE PRODUCT WAS USED FOR SURGERY WITHOUT ANY PROBLEM. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFTER SURGERY, THE SALES REP INSPECTED THE ACTUAL PRODUCT, AND THE FUNNEL HOLE WAS CLOGGED AND THE CAUSE WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001632 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY IRELAND - 3015516266 4047321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown