BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 6 CEM

    MDR report key: 9250211 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112840
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 4, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042402
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE OF 1818910-2020-07728. 1818910-2019-112840 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2020-07728 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED, IT WAS ALSO REPORTED THAT THE FEMUR WAS ALSO REVISED AND PATELLA WAS RETAINED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043359 ATTUNE FB TIB BASE SZ 6 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 1506-00-006 8322834 10603295042402

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ATTUNE CR FB INSRT SZ 6 8MM| ATTUNE CR FEM LT SZ 6 CEM| COMPETITOR BONE CEMENT| UNK KNEE PATELLA