BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    MDR report key: 1801264 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05325
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL AND FEMORAL LOOSENING AT THE CEMENT/BONE INTERFACE. POLY WEAR DISCOVERED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG, 41 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1063241

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention