BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA DIS AUG 8MM, SZ4,RGHT

    MDR report key: 1101756 · Received August 7, 2008

    Report

    Report Number
    1818910-2008-03108
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 BECAUSE OF LOOSENING WITH A FRACTURED CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA DIS AUG 8MM, SZ4,RGHT 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention