BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 23512256 · Received November 10, 2025

    Report

    Report Number
    1818910-2025-19443
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 22, 2025
    Manufacturer
    DEPUY IRELAND
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT WHEN OPENING THE CEMENT PACKAGE, THE PACKAGING WITH POWDER HAD A HOLE AND WAS SPILLING INTO THE SEALED PACKAGING AROUND IT. IT WAS CAUGHT BEFORE, NOT USED AND STILL SEALED.¿ PRODUCT NAME: SMARTSET HV BONE CEMENT 40G. PRODUCT CODE: 3092040. LOT NUMBER: 4625049. MANUFACTURING DATE: 2025-02-24. EXPIRY DATE: 2027-01-31. QUANTITY: (B)(4). THERE WAS 1 NON-CONFORMANCE ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 NAME: SMARTSET HV BONE CEMENT 40G. PRODUCT CODE: 3092040. LOT NUMBER: 4625049. MANUFACTURING DATE: 2025-02-24. EXPIRY DATE: 2027-01-31. QUANTITY: (B)(4). A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. DEVICE HISTORY REVIEW ==> THERE WAS 1 NON-CONFORMANCE ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE CEMENT PACKAGE, THE PACKAGING WITH POWDER HAD A HOLE AND, IT WAS SPILLING INTO THE SEALED PACKAGING AROUND IT. IT WAS CAUGHT BEFORE, NOT USED AND STILL SEALED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582314 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND 4625049 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown