BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIGHT MEDICAL TECHNOLOGY

    MDR report key: 2760203 · Received May 30, 2007

    Report

    Report Number
    2760203
    Event Type
    Injury
    Date Received
    May 30, 2007
    Date of Event
    April 16, 2007
    Report Date
    May 25, 2007
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A 2-INCISION HIP ARTHROPLASTY IN (B)(6) 2006, USING A WRIGHT MEDICAL COMPONENT. ON (B)(6) 2007, THE PT HEARD AND FELT A CRACKING SENSATION IN HIS LEFT HIP WITH SOME PAIN AND NUMBNESS IN HIS LEFT LEG. HE WAS FOUND TO HAVE A FRACTURE OF THE PROSTHESIS. HE WAS TRANSFERRED TO (B)(6), WHERE HE UNDEWENT REVISION OF THE FEMORAL COMPONENT OF HIS PROSTHETIC LEFT HIP. THE BROKEN DEVICE WAS A WRIGHT MEDICAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL TECHNOLOGY HIP PROSTHESIS JDI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention