BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 23096766 · Received September 19, 2025

    Report

    Report Number
    1818910-2025-16158
    Event Type
    Injury
    Date Received
    September 19, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    PMA / PMN Number
    K023012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H11 ADDITIONAL NARRATIVE: E3: INITIAL REPORTER IS A LAWYER.

    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,¿ LITIGATION RECORDS RECEIVED AD 3 SEPT 2025, ALLEGES THAT THE IMPLANTED DEVICE MALFUNCTIONED FOR SEVERAL MONTHS AFTER HAVING A TOTAL LEFT KNEE REPLACEMENT, LEADING TO SEVERE INJURY.¿ PRODUCT DESCRIPTION: SMARTSET HV BONE CEMENT 40G. PRODUCT CODE: 3092040. LOT NO: 8996057. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 7-DECEMBER-2018. EXPIRY DATE: 30-NOVEMBER-2020. 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 HV BONE CEMENT 40G. PRODUCT CODE: 3092040. LOT NO: 8996057. QUANTITY OF MANUFACTURED: (B)(4). DATE OF MANUFACTURING: 7-DECEMBER-2018. EXPIRY DATE: 30-NOVEMBER-2020 DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 8996057, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. CORRECTED INFORMATION: D4 (PRIMARY UDI #, AND EXPIRATION DATE).

    Description of Event or Problem · 0

    LITIGATION RECORDS ALLEGE THAT THE IMPLANTED DEVICE MALFUNCTIONED FOR SEVERAL MONTHS AFTER HAVING A TOTAL LEFT KNEE REPLACEMENT, LEADING TO SEVERE INJURY. AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764814 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 8996057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention