BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK(R) MP(R) STEM

    MDR report key: 2185498 · Received August 1, 2011

    Report

    Report Number
    9610548-2011-00010
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 18, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR 17292114 LOT NO: 0507010076. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED; UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) IS REPORTING ON BEHALF OF THE MANUFACTURER, (B)(4). INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE REVIEWED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH FORM HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS WRIGHT MEDICAL REPORT NUMBERS 1043534-2011-00372, 00373.

    Description of Event or Problem · 1

    ALLEGEDLY THE STEM BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) MP(R) STEM HIP COMPONENT JDI WRIGHT MEDICAL TECHNOLOGY, INC. 0507010076

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R