BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK(R) MP(R) STEM

    MDR report key: 2080399 · Received May 6, 2011

    Report

    Report Number
    9610548-2011-00001
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND. PRODUCT NOT RETURNED. SUPPLIER INVESTIGATION REVIEWED. IMPROPER SELECTION.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). WRIGHT MEDICAL TECHNOLOGY, INC., IS REPORTING ON BEHALF OF THE MANUFACTURER, WALDEMAR LINK GMBH & CO. 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 1043534-2011-00176, 00177, 00178.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) MP(R) STEM HIP COMPONENT JDI WALDEMAR LINK GMBH & CO. KG 0830111

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R