BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 10352078 · Received July 31, 2020

    Report

    Report Number
    1818910-2020-17304
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    September 16, 2019
    Report Date
    July 21, 2020
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AS PART OF INVESTIGATION (B)(4). THE DHR REVIEW FOUND ONE UNRELATED NON-CONFORMANCE ON THIS LOT. FINAL MICRO AND STERILITY TESTS PASSED.

    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

    PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT TKA REVISION TO TREAT PAIN SECONDARY TO LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED MASSIVE SYNOVITIS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS WELL-FIXED AND RETAINED. THE FEMORAL COMPONENT LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE SURGEON NOTES THERE WAS A 3 X 3 MM CYSTIC CHANGE TO THE FEMUR WITH MEDIAL FEMORAL BONE EROSION, WHICH WERE DEBRIDED AND REPAIRED WITH ALLOGRAFT. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016, DOI: (B)(6) 2019, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816230 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-35-500 8277459 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE PS FEM RT SZ 7 CEM| ATTUNE PS RP INSRT SZ 7 8MM| ATTUNE RP TIB BASE SZ 7 CEM| SMARTSET HV BONE CEMENT 40G