BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 16642557 · Received March 30, 2023

    Report

    Report Number
    1818910-2023-06961
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 30, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTQ
    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. THE INFORMATION RECEIVED, WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS, THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED. AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED, FOR THE FINISHED DEVICE PRODUCT CODE: 3172080, LOT CODE#: 3873517. AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE ARTIFICIAL HEAD REPLACEMENT SURGERY FOR FEMUR. IN THE SURGERY, THE AMPOULE OF THE CEMENT IN QUESTION HAD BROKEN. IT WAS FOUND WHEN UNSEALED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SPARE CEMENT. THERE WAS LESS THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176816 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY IRELAND - 9616671 3873517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown