BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 4 CEM

    MDR report key: 9198410 · Received October 16, 2019

    Report

    Report Number
    1818910-2019-110166
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    May 3, 2017
    Report Date
    September 25, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042389
    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). MDR UNDER MFR# 1818910-2019-110166 IS BEING RETRACTED SINCE IT WAS FOUND TO BE A DUPLICATE OF 1818910-2018-68470. MFR# 1818910-2018-68470 WILL BE KEPT FOR INVESTIGATION 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 25 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE AND OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING AND INSTABILITY. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE AT AN UNKNOWN INTERFACE. HE NOTED A WELL-FIXED FEMORAL COMPONENT, THOUGH IT WAS REVISED. THE SURGEON DID NOT COMMENT ON THE PATELLA, AND IT IS UNKNOWN IF THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2017 (RT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991965 ATTUNE FB TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 8221637 10603295042389

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention