BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA FEM STEM BOLT

    MDR report key: 1903288 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08706
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 13, 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
    AS
    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

    THE PT WAS REVISED TO ADDRESS ASCEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA FEM STEM BOLT 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 329766R

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention