BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN J & J PATELLA

    MDR report key: 625631 · Received June 10, 2005

    Report

    Report Number
    1818910-2005-00879
    Event Type
    Malfunction
    Date Received
    June 10, 2005
    Report Date
    May 20, 2005
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO THE POLY POPPED OFF THE METAL BACK OF THE IMPLANTED PATELLA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention