BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LCS LARGE PATELLA

    MDR report key: 1772361 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-05223
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY SIX YEARS AGO.

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO POLYWEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention