BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL TOTAL WRIST

    MDR report key: 758041 · Received September 1, 2006

    Report

    Report Number
    2028840-2006-00017
    Event Type
    Other
    Date Received
    September 1, 2006
    Date of Event
    August 18, 2006
    Report Date
    August 31, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE / PREVENTATIVE ACTION: GIVEN ALL INFORMATION MADE AVAILABLE AND THE ABSENCE OF ANY FINDINGS THAT WOULD SUGGEST A DEFICIENCY IN THE DEVICE, NO CORRECTIVE ACTION OR PREVENTATIVE ACTIONS ARE PRESCRIBED AT THIS TIME. THE CURRENT UNI2 PRODUCT INSERT CLEARLY AND SPECIFICALLY ADVISES THAT THE USE OF THIS DEVICE IN PATIENTS WITH POOR BONE QUALITY IS CONTRA-INDICATED. RISK ASSESSMENT: THE SUCCESS RATE OF THE UNI2 SYSTEM SINCE ITS RELEASE (TO DATE ONLY 0.3% OF THE 1500+ UNI2 IMPLANTS HAVE BEEN EXPLANTED) SUBSTANTIATES THIS SYSTEMS SAFETY AND EFFICACY, MINIMIZING ANY ASSOCIATED RISKS. POST-MARKET SERVEILLANCE: POST-MARKET SURVEILLANCE OF THE UNI2 SYSTEM WILL CONTINUE. ALL SOURCES AND TYPES OF PRODUCT INFORMATION WILL BE TAKEN INTO CONSIDERATION, REVIEWED AND DOCUMENTED BY KMI MANAGEMENT.

    Description of Event or Problem · 1

    ON AUG 24, 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT AND REPLACEMENT OF A UNI2 CARPAL POLY, PLATE AND SCREWS ON SIX DAYS EARLIER, TO ADDRESS PAIN REPORTED BY FEMALE PATIENT (AGE NOT REPORTED). THE EXPLANTED COMPONENTS WERE RETURNED TO KINETIKOS MEDICAL, INC. FOR EVALUATION. DR WAS DIRECTLY CONTACTED BY KMI SALE REPRESENTATIVE ONE DAY PRIOR TO ORIGINAL DATE, AND AGAIN ON TWO DAYS LATER, BY THE COMPANY'S MARKETING MANAGER. THIS EXPLANT WAS PERFORMED TO ADDRESS THE LOOSENING OF THE ULNAR-SIDE SCREW. PREVIOUS (DATE UNKNOWN) TO THE ORIGINAL UNI2 IMPLANT PROCEDURE, THE PATIENT HAD BEEN SUBJECTED TO A FOUR-CORNER FUSION THAT INCLUDED EXCISION OF THE SCAPHOID, WHICH DECREASED AVAILABLE BONE STOCK. THE ORIGINAL UNI2 IMPLANT SURGERY DATE WAS UNKNOWN. FOLLOWING THE EXPLANT, A NEW CARPAL POLY AND CARPAL PLATE WERE IMPLANTED, ALONG WITH TWO 35MM LENGTH BONE SCREWS TO MAXIMIZE PURCHASE. THE PATIENT'S POST-OPERATIVE PROGNOSIS WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TOTAL WRIST ORTHOPEDIC WRIST IMPLANT HRS KINETIKOS MEDICAL, INC. 26-5000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other