BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMIX CEMVAC

    MDR report key: 15397569 · Received September 10, 2022

    Report

    Report Number
    1818910-2022-17571
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Date of Event
    December 22, 2021
    Report Date
    September 10, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    KIH
    UDI-DI
    10603295202493
    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: A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE 831615, LOT - 21010243, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY FOR THE FEMUR WITH THE CEMENT, THE SYRINGE, AND THE OTHER COMPANY¿S CEMENT STEM. THE SURGEON PLANNED TO PUT THE THREE CEMENTS IN THE SYRINGE AND AGITATED THEM. THE SURGEON PREPARED AS PER THE PROCEDURE MANUAL AND PUT THE CEMENTS IN THE SYRINGE. HOWEVER, THE CEMENT POWDER WAS STUCK IN THE SYRINGE NOZZLE, AND THE SURGEON COULD NOT PUT THE ONE PACK OF THE CEMENT IN THE SYRINGE. THEREFORE, THE SURGEON USED THE OTHER COMPANY¿S CEMENT. SURGICAL DELAY OF 30 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820045 SMARTMIX CEMVAC BONE CEMENT : CEMENT DELIVERY DEVICES KIH DEPUY IRELAND - 9616671 83-1615 21010243 10603295202493

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown