BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3122834 · Received May 21, 2013

    Report

    Report Number
    1043534-2013-00832
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    October 28, 2011
    Report Date
    January 29, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES MADE OF THE PRODUCT. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224408 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT, CODE:LWJ LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 109926680

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention