BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL INSERT

    MDR report key: 633672 · Received September 8, 2005

    Report

    Report Number
    1818910-2005-01675
    Event Type
    Injury
    Date Received
    September 8, 2005
    Report Date
    August 13, 2005
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TIBIAL INSERT TOTAL KNEE REPLACEMENT JHW DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention