BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 506055 · Received January 9, 2004

    Report

    Report Number
    506055
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    November 10, 2003
    Report Date
    January 9, 2004
    Manufacturer
    BIOMET
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TREATED WITH SURGERY IN 2003 FOR RIGHT HIP FEMORAL NECK FRACTURE WITH A HEMIARTHROPLASTY USING A BIPOLAR PROSTHESIS. PT TRANSFERRED TO REHAB ON POST-OP DAY 3. THE FOLLOWING MONTH, PT SAT DOWN HARD ON TOILET SEAT, RIGHT HIP FOUND LATER TO BE DISLOCATED. PT UNDERWENT A CLOSED REDUCTION UNDER GENERAL ANESTHESIA THE DAY BEFORE. SIX DAYS LATER THE HIP DISLOCATED AGAIN, X-RAY SHOWED DISASSOCIATION OF THE RIGHT HIP BIPOLAR COMPLEX. A REVISION OF THE RIGHT HIP BIPOLAR WAS DONE ON THAT DATE, WITH THE PROSTHESIS COMPONENTS ALL REPLACED. THE HIP DISLOCATEED AGAIN 9 DAYS LATER, IT WAS RELOCATED, THE FOLLOWING DAY CLOSED REDUCTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET RINGLOC BI-POLAR FEMORAL CUP KWY BIOMET 11-165228 917840

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention