BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP ENDURANCE 80G

    MDR report key: 17383958 · Received July 24, 2023

    Report

    Report Number
    1818910-2023-14980
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 24, 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: 4047304 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY EXTRUSION TIME: 02 MIN 15 SEC, MIX CHARACTERISTICS: OK, SETTING TIME: 11 MIN 05 SEC. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION SETTING TIME WAS TESTED USING TM-T150. THE RECORDED SETTING MET 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: 4047304 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JULY 12, 2023, THE CEMENT IN QUESTION WAS USED IN THE SURGERY VIA THA FOR OA. IN THE SURGERY, THE CEMENT WAS UNABLE TO BE USED DUE TO LUMPS FORMING DURING MIXING OF THE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY WITHIN OPENING THE NEW CEMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993307 VMP ENDURANCE 80G BONE CEMENT : BONE CEMENT HTQ DEPUY ORTHOPAEDICS INC US 4047304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown