BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA TC3 FEM RT SZ3

    MDR report key: 1962341 · Received January 7, 2011

    Report

    Report Number
    1818910-2010-10095
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    PT REVISED FOR LOOSE FEMORAL COMPONENT, FOUND BROKEN FEMORAL ADAPTER AND POLYETHYLENE WEAR OF INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA TC3 FEM RT SZ3 87 JWH JWH DEPUY ORTHOPAEDICS, INC. NA 392009R

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention