BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1823105 · Received September 1, 2010

    Report

    Report Number
    1043534-2010-00354
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS COMPONENT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY THIS COMPONENT WAS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Description of Event or Problem · 1

    ALLEGEDLY THIS COMPONENT WAS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 0101009561

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R