BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL TOTAL WRIST (UTW)

    MDR report key: 728032 · Received June 20, 2006

    Report

    Report Number
    2028840-2006-00010
    Event Type
    Other
    Date Received
    June 20, 2006
    Date of Event
    May 24, 2006
    Report Date
    June 16, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL IMPLANT SURGERY WAS PERFORMED IN 2002 TO REDNESS A FAILED, UNRELATED PROCEDURE (PROXIMAL ROW CARPECTOMY FOLLOWING KIENBOCKS DISEASE) AT WHICH TIME A SIZE SMALL +1 CARPAL POLY COMPONENT WAS USED. IN 2004 A REVISION WAS PERFORMED TO ADDRESS AN ULNAR UTW 20MM BONE SCREW DETERMINED TO BE TOO LONG, CAUSING CMC 5 INTERFERENCE (15MM LENGTH SCREWS WERE NOT AVAILABLE AT THE TIME OF THE ORIGINAL UTW IMPLANT). THE PT THEREAFTER BEGAN AN AGGRESSIVE ATHLETIC TRAINING PROGRAM (NOT THERAPY) WHICH EVENTUALLY RESULTED IN CARPAL POLY / RADIAL COMPONENT DISLOCATION. CONSERVATIVE TREATMENT PROVED INEFFECTIVE. A SECOND REVISION WAS PERFORMED IN 2006, THIS TIME USING A +2 SIZE CARPAL POLY. THE EXPLANTED ORIGINAL +1 CARPAL POLY WAS FORWARDED TO KMI FOR EVALUATION, WHICH WAS RECEIVED AND EVALUATED THE FOLLOWING MONTH. IT WAS READILY APPARENT FROM THE RETURNED IMPLANT THAT THE PT HAD EXPERIENCED A SEVERE DISLOCATION AS EVIDENCE BY THE DAMAGE TO THE ARTICULATING AREA OF THE CARPEL POLY (DEEP, DISTINCT WEAR PATTERN INDICATING MISALIGNMENT INFRINGEMENT OF THE CORRESPONDING RADIAL COMPONENT). THE DEVICE HISTORY FILE OF THE CARPEL POLY PART LOT COULD NOT BE RESEARCH, AS THE 'OLD' MODEL UTW CARPAL POLY COMPONENTS DO NOT HAVE LOT NUMBER IDENTIFICATION ETCHINGS. THE NATURE OF THE DAMAGE OBSERVED DID NOT SUGGEST COMPONENT DEFECTS. FOLLOWING THE LATEST REVISION THE PT WAS PLACED IN A PLASTER CAST, THE NEW WRIST IMPLANT WAS REPORTED AS STABLE, AND HER PROGNOSIS IS VERY GOOD. GIVEN THE (EFFECTIVE) CHANGE TO A +2 SIZE, IT WOULD APPEAR THAT THE ORIGINAL CHOICE OF CARPAL POLY SIZE 1+ WAS LESS THAN OPTIMUM FOR THIS CASE, AS THE IMPINGEMENT / DISLOCATION EXPERIENCED IS ONE POSSIBLE OUTCOME IF A CARPAL POLY COMPONENT IS SELECTED THAT IS TOO SMALL FOR THE PTS PARTICULAR NEEDS, AND IN THIS CASE WAS FURTHER EXACERBATED BY THE PTS LIFESTYLE / ACTIVITY LEVEL.

    Description of Event or Problem · 1

    IN 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT AND REPLACEMENT OF A UTW CARPAL PLATE IMPLANT OWING TO PAIN ASSOCIATED WITH DISLOCATION. THE EXPLANTED COMPONENT WAS RETURNED TO KMI FOR EVALUATION 8 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TOTAL WRIST (UTW) ORTHOPEDIC WRIST IMPLANT KWM KINETIKOS MEDICAL, INC. 16-5000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other