BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMI-KINETIKOS MEDICAL INC.

    MDR report key: 1275465 · Received December 25, 2008

    Report

    Report Number
    MW5009416
    Event Type
    Injury
    Date Received
    December 25, 2008
    Date of Event
    April 23, 2004
    Report Date
    December 1, 2008
    Manufacturer
    KMI
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL WRIST ARTHROPLASTY LEFT IN 2004. ALWAYS HAD PROBLEMS WITH DEVICE FROM DAY 1 OF "SURGERY". WENT TO DIFFERENT DOCTORS. IN 2007, HAD SEVERE PAIN, AND THE DEVICE HAD LOOSEN AND SCREWED, ONE OF THEM COMPLETELY BROKEN INTO. THE PROSTHESIS HAD 3 SCREWS. I HAD SURGERY AGAIN IN 2008 TO REPLACE THE PROSTHESIS. I ASKED PATTI CONDEN, IF ANY PROBLEM WITH DEVICE, SHE SAID YES, LOOSEN. I HAVE THE PROSTHESIS HERE WITH ME, AFTER REMOVED. DIAGNOSIS OR REASON FOR USE; ARTHRITIS AND SCAPHOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMI-KINETIKOS MEDICAL INC. NONE HWC KMI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S