BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 23534761 · Received November 12, 2025

    Report

    Report Number
    1818910-2025-19657
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 12, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT LIQUID VIAL IN CEMENT BROKE IN PACKAGING BEFORE BEING OPENED. IT WAS UNABLE TO BE USED IN SURGERY. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE¿. PRODUCT DESCRIPTION: SMARTSET MV 40G - EO. PRODUCT CODE: 3122040. LOT NO: 4591842. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 16-SEP-2024. EXPIRY DATE: 31-AUG-2026. 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: PRODUCT DESCRIPTION: SMARTSET MV 40G - EO. PRODUCT CODE: 3122040. LOT NO: 4591842. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 16-SEP-2024. EXPIRY DATE: 31-AUG-2026. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: H4.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 LIQUID VIAL IN CEMENT BROKE IN PACKAGING BEFORE BEING OPENED. IT WAS UNABLE TO BE USED IN SURGERY. AFFECTED SIDE: UNKNOWN KNEE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601440 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 4591842 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female