BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 3 CEM

    MDR report key: 9268501 · Received November 1, 2019

    Report

    Report Number
    1818910-2019-113725
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    August 28, 2018
    Report Date
    October 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295042372
    PMA / PMN Number
    K101433
    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). THIS IS A DUPLICATE REPORT OF 1818910-2018-70005. 1818910-2019-113725 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2018-70005 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

    MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA DUE TO PAIN, DISCOMFORT, STIFFNESS, SWELLING, AND ARTHROFIBROSIS. NO PRODUCTS WERE REVISED DURING THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO STIFFNESS AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOE: (B)(6) 2014; DOR: (B)(6) 2018 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059776 ATTUNE FB TIB BASE SZ 3 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US 3538623 10603295042372

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ATTUNE MEDIAL DOME PAT 32MM| COMPETITOR BONE CEMENT| COMPETITOR BONE CEMENT