BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 7 CEM

    MDR report key: 8866271 · Received August 6, 2019

    Report

    Report Number
    1818910-2019-100233
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    December 12, 2017
    Report Date
    July 18, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042419
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2018-65503. 1818910-2019-100233 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2018-65503 WILL BE KEPT FOR INVESTIGATIONAL 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

    THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, A DEEP "CLUNKING" SENSATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SIGNIFICANT VASTUS MEDIALIS OBLIQUE ATROPHY. THE FEMORAL AND PATELLA COMPONENTS WERE BOTH WELL-FIX, THE FEMORAL WAS REVISED WHILE THE SURGEON DECIDED TO NOT REVISE THE PATELLA. THE SURGEON NOTED THE TIBIAL TRAY APPEARED TO BE WELL-FIXED, HOWEVER, AFTER EASY REMOVAL THERE WAS NO CEMENT ATTACHED TO THE BACKSIDE OF THE TIBIAL COMPONENT. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2017; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660023 ATTUNE FB TIB BASE SZ 7 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 7856120 10603295042419

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM