BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFEMUR

    MDR report key: 1519402 · Received October 13, 2009

    Report

    Report Number
    1519402
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Date of Event
    September 28, 2009
    Report Date
    October 13, 2009
    Manufacturer
    WRIGHT MEDICAL SYSTEMS
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH BILATERAL TOTAL HIP REPLACEMENTS FOR AVASCULAR NECROSIS. ON DAY OF EVENT, PATIENT STATES HE WAS STANDING AND WHEN HE TWISTED TO THE RIGHT, HE FELT A POP IN HIS LEFT HIP CAUSING HIM TO FALL TO THE GROUND. HE WAS THEN UNABLE TO AMBULATE OR WEIGHT BEAR. HE WAS ADMITTED TO THE EMERGENCY DEPARTMENT AND XRAY REVEALED A FRACTURE OF THE NECK OF THE FEMORAL COMPONENT OF THE ARTHROPLASTY DEVICE WITH SUPERIOR MIGRATION OF THE LEFT FEMUR. FRACTURED MODULAR NECK, WRIGHT MEDICAL BIG FEMORAL HEAD, METAL ON METAL PROSTHESIS. MANUFACTURER RESPONSE (AS PER REPORTER) FOR HIP PROSTHESIS, MODULAR FEMORAL NECK, BIG, METAL ON METAL PROSTHESISFILING FDA REPORT

    Description of Event or Problem · 1

    PATIENT WITH BILATERAL TOTAL HIP REPLACEMENTS FOR AVASCULAR NECROSIS. ON DAY OF EVENT, PATIENT STATES HE WAS STANDING AND WHEN HE TWISTED TO THE RIGHT, HE FELT A POP IN HIS LEFT HIP CAUSING HIM TO FALL TO THE GROUND. HE WAS THEN UNABLE TO AMBULATE OR WEIGHT BEAR. HE WAS ADMITTED TO THE EMERGENCY DEPARTMENT AND XRAY REVEALED A FRACTURE OF THE NECK OF THE FEMORAL COMPONENT OF THE ARTHROPLASTY DEVICE WITH SUPERIOR MIGRATION OF THE LEFT FEMUR. FRACTURED MODULAR NECK, WRIGHT MEDICAL BIG FEMORAL HEAD, METAL ON METAL PROSTHESIS. MANUFACTURER RESPONSE (AS PER REPORTER) FOR HIP PROSTHESIS, MODULAR FEMORAL NECK, BIG, METAL ON METAL PROSTHESISFILING FDA REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR PROSTESIS, HIP, MODULAR NECK JDI WRIGHT MEDICAL SYSTEMS * 066354490

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES| NO OTHER THERAPIES