BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 16993454 · Received May 24, 2023

    Report

    Report Number
    1818910-2023-10786
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 24, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT:545050501 /LOT: 8647290 COMBINATION. BASED ON THE INABILITY TO FIND ANY NC¿S AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DMF# - 13704. TRADE NAME GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH 1.0G ACTIVE IN OUR CEMENTS. 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

    PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS DEPUY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897815 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-50-501 8647290 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention ATTUNE PS FEM RT SZ 7 CEM| ATTUNE PS RP INSRT SZ7 5MM| ATTUNE RP TIB BASE SZ 6 CEM| SMARTSET GMV 40G US EO