BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY INC.

    MDR report key: 511131 · Received February 11, 2004

    Report

    Report Number
    MW4003682
    Event Type
    Injury
    Date Received
    February 11, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 TALAR 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