BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV ENDURANCE 80G

    MDR report key: 23380823 · Received October 24, 2025

    Report

    Report Number
    1818910-2025-18237
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    October 6, 2025
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168355
    PMA / PMN Number
    K042591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    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, ¿PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT THE IMPLANT CEMENT INTERFACE. DOI: (B)(6) 2013 DOR: (B)(6)(2025) AFFECTED SIDE: RIGHT KNEE." PRODUCT DESCRIPTION: SMARTSET MV ENDURANCE BONE CEMENT, 80G PRODUCT CODE: 3102080 LOT NUMBER: 3557277 QUANTITY OF MANUFACTURED: (B)(4) MANUFACTURING DATE: MAR-2013 EXPIRY DATE: 31-JAN-2016. TESTING COULD NOT BE COMPLETED AS THE RETAINED SAMPLES ARE NO LONGER AVAILABLE FOR TESTING. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS BATCH. ALL QC AND MICROBIOLOGY TESTING MET RELEASE SPECIFICATION (REF: MS-007 BONE CEMENT: MASTER SPECIFICATION: SMARTSET MV). 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 ENDURANCE BONE CEMENT, 80G PRODUCT CODE: 3102080 LOT NUMBER: 3557277 QUANTITY OF MANUFACTURED: (B)(4) MANUFACTURING DATE: MAR-2013 EXPIRY DATE: 31-JAN-2016. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT). CORRECTED: D3. 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 PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516885 SMARTSET MV ENDURANCE 80G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3557277 10603295168355

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention ATTUNE FB TIB BASE SZ 7 CEM.| ATTUNE MEDIAL DOME PAT 38MM.| ATTUNE PS FB INSRT SZ 8 6MM.| ATTUNE PS FEM RT SZ 8 CEM.