BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 5 CEM

    MDR report key: 9224333 · Received October 23, 2019

    Report

    Report Number
    1818910-2019-111328
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    December 21, 2016
    Report Date
    October 1, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2019-88197. 1818910-2019-111328 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-88197 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Additional Manufacturer Narrative · 1

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

    ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING, AND EFFUSION. THE SURGEON NOTED THE PATELLAR COMPONENT WAS WELL-FIXED AND NOT REVISED. HE INDICATED THE TIBIAL COMPONENT HAD COMPLETELY DE-BONDED FROM THE CEMENT, AT THE TRAY/CEMENT INTERFACE. THE SURGEON NOTED SOME POSTERIOR LYSIS BOTH MEDIALLY AND LATERALLY TO THE FEMUR. THE FEMUR WAS REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND SMARTSET CEMENT X 3. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2013 (CEMENT, TIBIAL, FEMORAL, PATELLAR COMPONENTS); DOI: (B)(6) 2015 (TIBIAL INSERT); DOR: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018642 ATTUNE FB TIB BASE SZ 5 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 3613583 10603295042396

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention