BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY KNEE

    MDR report key: 1243062 · Received November 21, 2008

    Report

    Report Number
    1818910-2008-05482
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 14, 2008
    Report Date
    October 22, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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

    PATIENT CONTACTED DEPUY VIA THE WEBSITE ALLEGING THAT HIS RIGHT KNEE WAS FIRST REVISED IN 2008, BECAUSE HIS PATELLA BECAME LOOSE. HE WAS REVISED AGAIN THE FOLLOWING MONTH, TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY KNEE TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A Required Intervention