BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 17164993 · Received June 20, 2023

    Report

    Report Number
    1818910-2023-12585
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    June 10, 2023
    Report Date
    June 20, 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). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3172080 ,LOT NUMBER:3952644, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THERE ARE TWO PRODUCT NON-CONFORMANCES ON THIS LOT, NEITHER NON-CONFORMANCE WOULD HAVE AN ADVERSE EFFECT ON THE CEMENT¿S PERFORMANCE. THE RETAINED SAMPLES WERE TESTED IN TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY EXTRUSION TIME: 02 MIN 15 SEC MIX CHARACTERISTICS: AS EXPECTED. SETTING TIME: 12 MIN 03 SEC THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPES AND MEETS THE APPROPRIATE CONTROL SPECIFICATION (MS-022, MASTER SPECIFICATION FOR VACUMIX PLUS ENDURANCE BONE CEMENT). SETTING TIME WAS TESTED USING TM-T150. THE SETTING TIME RECORDED MEETS THE CONTROL SPECIFICATION OF 10 MIN 00 SEC TO 14 MIN 30 SEC. 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:3952644, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION 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 (B)(6) 2023, THE CEMENT IN QUESTION WAS USED FOR THE SURGERY VIA THA FOR OA. THE PRODUCT IN QUESTION WAS USED WITH A CEMENT GUN, BUT DESPITE THE LOW VISCOSITY OF THE CEMENT, IT WAS VERY HARD AND DIFFICULT TO EXTRUDE. THE CEMENT IS HARDER TO PUSH OUT THAN BEFORE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647153 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY ORTHOPAEDICS INC US 3952644

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown