BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK J & J PATELLA

    MDR report key: 442371 · Received February 7, 2003

    Report

    Report Number
    1818910-2003-00051
    Event Type
    Malfunction
    Date Received
    February 7, 2003
    Date of Event
    January 9, 2003
    Report Date
    February 7, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT IS BEING REVISED DUE TO POLY WEAR OF TIBIAL INSERT. THIS WILL BE THE SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK J & J PATELLA TOTAL KNEE PROSTHESIS HTG DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other