BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1862762 · Received October 8, 2010

    Report

    Report Number
    1043534-2010-00411
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    April 1, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00412, 00413, 00414.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT, THE USER OF THE DEVICE WAS INCORRECTLY LISTED AS THE RISK MANAGER. THE CORRECTED INFORMATION IS PHYSICIAN.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT HAD FINISHED PAINTING AND WAS CLEANING HIS PAINT BRUSHES WHEN HE HEARD A "CRACK" AND THEN HIS LEG GAVE WAY.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 058594232

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R