BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY INC.

    MDR report key: 519100 · Received January 7, 2004

    Report

    Report Number
    MW1031630
    Event Type
    Injury
    Date Received
    January 7, 2004
    Date of Event
    March 11, 2003
    Report Date
    January 7, 2004
    Manufacturer
    DEPUY INC.
    Product Code
    HSN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/18/04: THE TOTAL IMPLANT DURATION TIME FOR THE DEVICE WAS APPROX FIVE YEARS AND TWO MONTHS. THE DATE OF IMPLANTATION IN THE USER FACILITY REPORT IS INCORRECTLY GIVEN. DEPUY'S MEDWATCH REPORT NUMBER FOR THIS EVENT IS 1818910-2004-00082. THE INITIAL REPORT WAS SUBMITTED ON FEBRUARY 11, 2004, AND A FOLLOW-UP REPORT WAS SENT ON MARCH 9, 2004. AN ADD'L FOLLOW-UP REPORT WILL BE SENT SHORTLY TO CORRECT THE DATE OF IMPLANTATION. THIS MEDWATCH REPORT RELATES TO PRODUCT CODE (CATALOG NUMBER) 1542-11-500. NO MEDWATCH WAS SUBMITTED FOR PRODUCT CODE (CATALOG NUMBER) 1542-45-999, AS THE POTENTIAL FOR PRODUCT CAUSE OR CONTRIBUTION TO THE NEED FOR REVISION SURGERY WAS NOT ESTABLISHED FOR THIS PRODUCT.

    Description of Event or Problem · 1

    PT ADMITTED WITH A DIAGNOSIS OF FAILED RIGHT TOTAL ANKLE ARTHROPLASTY WITH FRACTURE OF TALUS UNSETTLING THE TALAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY INC. AGILITY ANKLE TOLAR COMPONENT HSN DEPUY INC. * 396421004
    2 DEPUY INC. AGILITY ANKLE TOLAR COMPONENT HSN DEPUY INC. * 307240002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention