BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 3 CEM

    MDR report key: 8983047 · Received September 10, 2019

    Report

    Report Number
    1818910-2019-103798
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    April 13, 2016
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295042570
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    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 1818910-2016-17631. 1818910-2019-103798 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2016-1763 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

    MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 20 AUGUST 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ATTUNE KNEE SYSTEM WAS UTILIZED IN THE PROCEDURE, AS WELL AS SMARTSET CEMENT. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND PAIN. THE SURGEON INDICATED TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND WAS EASILY REMOVED. THE SURGEON NOTED THERE WAS MINIMAL BONE LOSS. THE SURGEON REPORTED BOTH THE FEMORAL COMPONENT AND THE PATELLA WERE BOTH SOLID. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED, THE SURGEON NOTED THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. ATTUNE TIBIAL BASE AND INSERT WERE UTILIZED IN THE REVISION. COMPETITOR CEMENT WAS UTILIZED. DOI: (B)(6) 2014. DOR: (B)(6) 2016 (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775971 ATTUNE RP TIB BASE SZ 3 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 3555161 10603295042570

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R