BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULNAR COMPONENT

    MDR report key: 660182 · Received January 4, 2006

    Report

    Report Number
    1818910-2006-00131
    Event Type
    Injury
    Date Received
    January 4, 2006
    Date of Event
    December 9, 2005
    Report Date
    December 9, 2005
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE HUMERAL AND ULNAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ULNAR COMPONENT TOTAL ELBOW REPLACEMENT KWJ DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention