BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM NRHFEM W/PIN MEDLFT 71X66

    MDR report key: 1911656 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-08828
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K870730
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 A FRACTURED FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM NRHFEM W/PIN MEDLFT 71X66 87JWH JWH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 115401LA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention