BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 17097359 · Received June 9, 2023

    Report

    Report Number
    1818910-2023-11943
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    February 16, 2016
    Report Date
    June 9, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). E3 INITIAL REPORTER OCCUPATION: (B)(6). DMF# (B)(4). 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.

    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 MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 7970381, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    LITIGATION COMPLAINT RECEIVED AD (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451963 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-35-500 7970381 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention ATTUNE CR FEM RT SZ 6 CEM.| ATTUNE CR RP INSRT SZ 6 6MM.| ATTUNE MEDIAL DOME PAT 41MM.| ATTUNE RP TIB BASE SZ 6 CEM.