BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 17111577 · Received June 12, 2023

    Report

    Report Number
    1818910-2023-12130
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    July 12, 2022
    Report Date
    June 12, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. REVIEW OF PHOTO/X-RAY EVIDENCE FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. THE REPORTED CONDITION WAS NOT CONFIRMED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (3092040/9832744) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    FAILED GLEONOID. ANCHOR PEG GLENOID WAS LOOSE. THE CEMENT APPEARED TO NOT ADHERE PROPERLY TO THE BONE INTERFACE. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588382 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY IRELAND - 9616671 3092-040 9832744 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention APG+ 2.5MM BREAKAWAY GUIDE PIN.| APG+ 2.5MM BREAKAWAY GUIDE PIN.| APG+ QC CENT BIT 40 44.| APG+ QC PERIPH BIT.| CROSSLINK ANCHOR PG GLENOID 40.| GLBL UNITE ANT BODY 135 SZ 12.| GLOBAL UNITE HEAD 44X15 STD.| GLOBAL UNITE STD STEM SZ 12.