BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 9202128 · Received October 17, 2019

    Report

    Report Number
    1818910-2019-110332
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    December 4, 2018
    Report Date
    September 24, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). MFR#1818910-2019-110332 IS BEING RETRACTED SINCE IT WAS FOUND TO BE A DUPLICATE OF MFR# 1818910-2019-79537. MFR#1818910-2019-79537 WILL BE KEPT FOR INVESTIGATION PURPOSES

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 24 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE WITH NO CEMENT ADHERING TO THE IMPLANT. HE NOTED THE FEMORAL COMPONENT WAS NOT LOOSE AND WAS NOT REVISED. THE SURGEON INDICATED THE PATELLAR COMPONENT WAS STABLE AND NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S TIBIAL COMPONENTS AND CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014; DOR: (B)(6) 2018; (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996675 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 7786750 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention