BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED

    MDR report key: 6129893 · Received November 28, 2016

    Report

    Report Number
    3010536692-2016-01460
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    July 18, 2016
    Report Date
    August 23, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TREND WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING REVISION SURGERY SURGEON DISCOVERED A FRACTURE OF THE PROSTHETIC FEMORAL STEM. PATIENT WAS ORIGINALLY RECEIVING A CUP REPLACEMENT. THE PATIENT WAS BORN IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779345 PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. V11287328

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention