BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 3 CEM

    MDR report key: 9250405 · Received October 29, 2019

    Report

    Report Number
    1818910-2019-112845
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    January 4, 2017
    Report Date
    October 4, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042372
    PMA / PMN Number
    K101433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). MFR# 1818910-2019-112845 IS BEING RETRACTED SINCE IT WAS FOUND TO BE A DUPLICATE OF 1818910-2018-61605. MFR# 1818910-2018-61605 WILL BE KEPT FOR INVESTIGATION 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 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL TRAY MIGRATION, MALPOSITIONING, AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED EFFUSION, MILD POLY WEAR-TYPE SYNOVITIS, AND TIBIAL BONE LOSS. THE PATELLA WAS NOT RESURFACED DURING THE PRIMARY OPERATION. COMPETITOR CEMENT WAS 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
    1044368 ATTUNE FB TIB BASE SZ 3 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 6299344 10603295042372

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention