BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 10593729 · Received September 28, 2020

    Report

    Report Number
    1818910-2020-20997
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    September 15, 2020
    Report Date
    May 10, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174288
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: 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 REPORT, A FOLLOW-UP REPORT 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED 08 NOVEMBER 2019. 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 31 MARCH 2019.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). REPORTS UNDER MRN 1818910-2020-20997 ARE BEING RETRACTED AS THEY ARE A DUPLICATE OF REPORTS UNDER MRN 1818910-2021-10615. ALL FUTURE REPORTS WILL BE REPORTED UNDER MRN 1818910-2021-10615. REPORTS UNDER MRN 1818910-2020-20997 ARE BEING RETRACTED AS THEY ARE A DUPLICATE OF REPORTS UNDER MRN 1818910-2021-10615.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. A FULL REVISION WAS PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2020; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059149 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-35-500 8525085 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 5 8MM| ATTUNE PS FEM LT SZ 5 NAR CEM| ATTUNE FB TIB BASE SZ 4 CEM| ATTUNE MEDIAL DOME PAT 32MM| ATTUNE PS FB INSRT SZ 5 8MM| ATTUNE PS FEM LT SZ 5 NAR CEM