BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 1910965 · Received November 30, 2010

    Report

    Report Number
    1043534-2010-00487
    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. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00486. THIS EVENT OCCURRED IN (B)(6) .

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. COMPLAINT HISTORY REVIEWED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. ANALYSIS SHOWS NO TREND FOR THIS ITEM/LOT. PRODUCT NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. U11110113

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R