BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LCS PATELLA

    MDR report key: 1232252 · Received November 13, 2008

    Report

    Report Number
    1818910-2008-04997
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO CONTINUED PAIN. IT WAS REPORTED THAT THE PATELLA WAS NOT TRACKING WELL AND HAD CAUSED CARTILAGE DAMAGE TO THE FEMORAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LCS PATELLA TOTAL KNEE REPLACEMENT HTG DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention