BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RENAISSANCE(R) STEM

    MDR report key: 1912581 · Received December 2, 2010

    Report

    Report Number
    1043534-2010-00492
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    October 31, 2010
    Report Date
    July 26, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051995
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00491, 00493.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPNENT.

    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) RENAISSANCE(R) STEM HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 066346675

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R