BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL TOTAL WRIST

    MDR report key: 731342 · Received June 30, 2006

    Report

    Report Number
    2028840-2006-00011
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 16, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE LIMITED INFORMATION MADE AVAILABLE, THE LACK OF COMPONENTS FOR EVALUATION AND THE ABSENCE OF ANY PRODUCT EXPERIENCE TRENDS THAT WOULD SUGGEST QUESTIONABLE PRODUCT DESIGN OR DEFECTS, NO CORRECTIVE OR PREVENTIVE ACTIONS CAN BE PRESCRIBED AT THIS TIME. THE DOCUMENTED SUCCESS RATE OF THE UNIVERSAL2 TOTAL WRIST SYSTEM ( A TOTAL OF 3 EXPLANTS- INCLUDING THIS ONE -OUT OF THE 750+ IMPLANTED TO DATE) DEMONSTRATES THE PRODUCT'S SAFETY AND EFFICACY, PRECLUDING A NEED TO ASSESS DESIGN RISKS ASSOCIATED WITH THIS DEVICE NOT PREVIOUSLY CONSIDERED. POST-MARKET SURVEILLANCE OF THE UNI2 IMPLANT SYSTEM WILL CONTINUE. ALL SOURCES AND TYPES OF PRODUCT INFO WILL BE TAKEN INTO CONSIDERATION, REVIEWED BY KMI MGMT PER QSP-157, AND WILL BE EMPLOYED TO FACILITATE INCREMENTAL IMPROVEMENTS AND/OR ENSURE THE SAFETY AND EFFICACY OF THIS PRODUCT SYSTEM.

    Description of Event or Problem · 1

    IN 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT AND REPLACEMENT OF A UNI2 CARPAL PLATE IMPLANT ON THIS SAME DATE. KINETIKOS MEDICAL, INC., WAS INFORMED THAT THE EXPLANT AND REPLACEMENT OF A UNIVERSAL2 TOTAL WRIST SYSTEM CARPAL PLATE HAD BEEN PERFORMED. THE EXPLANT WAS PERFORMED BY DR. PRODUCT REPORT WAS INITIATED TO FACILITATE DOCUMENTATION OF THE INVESTIGATION. AN INVESTIGATION WAS CONDUCTED TO DETERMINE WHETHER THIS INCIDENT WAS REPORTABLE UNDER THE MEDICAL DEVICE REPORTING REGULATION (21CFR803) AND TO DETERMINE, IF POSSIBLE, THE ROOT CAUSE AND PRESCRIBE CORRECTIVE AND/OR PREVENTIVE ACTIONS. DETERMINING WHETHER EVENT IS REPORTABLE: THE INFORMATION PROVIDED INDICATED THAT SURGICAL INTERVENTION WAS DEEMED APPROPRIATE BY THE ATTENDING PHYSICIAN. DR BOYER ADVISED THAT THE IMPLANT HAD PERFORMED AS DESIGNED, ADDRESSING THE PATIENT'S WRIST ARTHRITIS AND RESTORING MAXIMUM ARTICULATION FROM THE TIME OF ITS ORGINAL IMPLANTATION. HE ADVISED THAT THE PATIENT HAD NOT VOLUNTEERED ANY INFORMATION THAT MAY HAVE SUGGESTED A TRAUMATIC EPISODE THAT MAY HAVE RESULTED IN A BROKEN CARPAL PLATE STEM. THERE WAS CONFLICTING INFORMATION AS TO THE ORIGINAL IMPLANT DATE, THE MOST RECENT BEING SOMETIME IN 2004, THE OLDEST 2002. FOR THE EXPLANT/REPLACEMENT PRCEDURE, THE EXISTING (BROKEN) CARPAL PLATE STEM WAS LEFT IN PLACE, THE ORIGINAL PLATE AND CARPAL POLY WERE EXPLANTED, AND THE NEW PLATE AND POLY COMPONENTS WERE IMPLANTED WITH THE STEM PARALLEL TO THE ORIGINAL (LEAST INVASIVE APPROACH). AFTER CONTACTING THE HOSPITAL OPERATING ROOM, PATHOLOGY LAB AND MATERIALS DEPARTMENT, IT WAS DETERMINED THAT THE EXPLANTED COMPONENTS HAD ALREADY BEEN DISCARDED AND WERE; THEREFORE, NOT AVAILABLE FOR EVALUATION BY KMI. WHILE DR CONFIDED TO KMI THAT HE STRONGLY SUSPECTED EITHER A TRAUMATIC EPISODE OR OTHER UNDUE OR UNANTICIPATED STRESS LOADING OF THE WRIST JOINT, THE PATIENT DID NOT VOLUNTEER ANY SUCH INFORMATION OR DETAILS. THE PATIENT'S POST-SURGICAL PROGNOSIS IS REPORTED AS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other