BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 13000845 · Received December 14, 2021

    Report

    Report Number
    1818910-2021-27841
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    April 21, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: BFARM DHR REVIEW WAS PERFORMED FOR PRODUCT/LOT COMBINATION 3095040/8801946. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 11-MAY-2018. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: ONE UNRELATED NC ((B)(4)) WAS FOUND. THERE IS NO CORRELATION TO THE REPORTED EVENT. 4) EXPIRY DATE: 30-APR-2020. 5) IFU REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT THE SAME/SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. DMF# - (B)(4), 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.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL BASE PLATE, TIBIAL STEM, TIBIAL INSERT, AND FEMUR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901301 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 8801946

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention ATTUNE CEMENTED STEM 14X80MM| ATTUNE PS FB INSRT SZ 6 5MM| ATTUNE PS FEM RT SZ 6 CEM| ATUNE CRS FB TIB BASE SZ 6 CEM| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 40G