BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    MDR report key: 3122913 · Received May 21, 2013

    Report

    Report Number
    1043534-2013-00833
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 9, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K004043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 1043534-2013-00600, 00601.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY PER SURGEON, ONE PATENT 2 WEEKS AGO WITH A TYPICAL PAIN FOLLOWING THR. HER COBALT IONS ARE ELEVATED, AND SHE DOES NOT HAVE METAL-METAL HEAD. MARS PROTOCOL MRI WAS SCHEDULED TO LOOK FOR PSEUDOTUMOR/ALTR/ALVAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224950 LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD HIP COMPONENT, CODE:JDL JDL WRIGHT MEDICAL TECHNOLOGY, INC. 0901194834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention