BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM

    MDR report key: 1780007 · Received August 2, 2010

    Report

    Report Number
    1043534-2010-00326
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    June 22, 2010
    Report Date
    May 2, 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
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00325, 00327. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. PRODUCT CONFORMANCE COULD NOT BE DETERMINED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    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 HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. X07428409

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R