BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ENGAGE STEM

    MDR report key: 1905416 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-08520
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 29, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK001991
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY ENGAGE STEM TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention