BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 17650881 · Received August 30, 2023

    Report

    Report Number
    1818910-2023-17849
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 30, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DMF# - 13704. TRADE NAME (B)(6). ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH 1.0G ACTIVE IN OUR CEMENTS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CMV CEMENT HARDENED TOO QUICKLY AND WAS NOT ABLE TO SHOOT IN A CEMENT GUN. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469677 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY IRELAND - 9616671 4047303 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown