BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 16768615 · Received April 19, 2023

    Report

    Report Number
    1818910-2023-08199
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 19, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    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). 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. 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: 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: DEVICE HISTORY REVIEWED: 0 NON-CONFORMANCE ON THIS LOT NUMBER:3873517; NO IMPACT ON CEMENT PERFORMANCE. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CEMENT BECAME LUMPY DURING MIXING AND COULD NOT BE USED. THE USE OF THE PRODUCT WAS IMMEDIATELY DISCONTINUED, AND THE SURGERY WAS CONTINUED KNEADING BY HAND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548284 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY ORTHOPAEDICS INC US 3873517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown