BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 12810975 · Received November 15, 2021

    Report

    Report Number
    1818910-2021-25086
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 15, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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. 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: DHR REFERENCED FROM (B)(4). DEVICE HISTORY REVIEWED FOR SMARTSET GMV 40G US EO (B)(4), LOT:2980913: NO NON CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED.

    Description of Event or Problem · 0

    THE PATIENT WAS REVISED DUE TO TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. DOI: (B)(6) 2010; DOR: (B)(6) 2021; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713668 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-50-501 2980913 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention MBT CEM KEEL TIB TRAY SZ4| PFC SIGMARP STB TB IN 4 12.5| PFC*SIGMA/OV/DOME PAT 3PEG,35| SIGMA PS CEM FEM SZ4N L| SMARTSET GMV 40G US EO| SMARTSET GMV 40G US EO