BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1910938 · Received November 30, 2010

    Report

    Report Number
    1043534-2010-00486
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 28, 2010
    Report Date
    March 30, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00487. THIS EVENT OCCURRED IN (B)(6) .

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD (DHR) REVIEWED. REVIEWED PACKAGE INSERT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE CURRENT PACKAGE INSERT FOR THIS PRODUCT, "FATIGUE FRACTURE OF THE PROSTHETIC COMPONENT CAN OCCUR AS A RESULT OF TRAUMA, STRENUOUS ACTIVITY, IMPROPER ALIGNMENT, INCOMPLETE IMPLANT SEATING, DURATION OF SERVICE, LOSS OF FIXATION, NON-UNION, OR EXCESSIVE WEIGHT". THE DHR HAS BEEN REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. WITHOUT THE RETURN OF THE PRODUCT ADDITIONAL INVESTIGATION IS NOT POSSIBLE. CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. U1088873

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R