BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 2963291 · Received February 15, 2013

    Report

    Report Number
    1043534-2013-00276
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K111699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00274, 00275, 00277.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY SURGEON WAS CONCERNED ABOUT METALLOSIS; REMOVED ALL IMPLANTS. CULTURES SHOW AN INFECTION SO NO OTHER IMPLANTS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67637 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 027407312

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention