BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM STD

    MDR report key: 655631 · Received December 21, 2005

    Report

    Report Number
    1818910-2005-02795
    Event Type
    Injury
    Date Received
    December 21, 2005
    Date of Event
    November 29, 2005
    Report Date
    December 1, 2005
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO THE PATELLA CAME OFF THE METAL BACK WHEN A SCOPE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3PEG MOD ROT PAT CEM STD TOTAL KNEE PROSTHESIS HTG DEPUY ORTHOPAEDICS, INC. NA YR1EN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention