BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 754151 · Received August 21, 2006

    Report

    Report Number
    2028840-2006-00016
    Event Type
    Other
    Date Received
    August 21, 2006
    Date of Event
    July 12, 2006
    Report Date
    August 18, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR WAS CONTACTED DIRECTLY BY PHONE ON 8/2/2006 TO REVIEW PARTICULARS OF THIS CASE. THIS DR HAD NOT PERFORMED THE ORIGINAL IMPLANT OPERATION IN 2004. THE PT REPORTED PAIN, AND AS THE SUBTALAR MBA HAD COMPLETED THE CORRECTION OF HIS HYPERPRONATED LEFT FOOT, IT WAS DECIDED TO REMOVE THE DEVICE. UPON REMOVAL, THE PHYSICIAN DID NOT OBSERVE ANY DEVICE DEFECTS, DEFORMITIES OR DAMAGE. SHE ADVISED THAT THE DEVICE WAS NOT AVAILABLE FOR EVAL BY KMI, NOR WAS ANY SIZE OR LOT INFO AVAILABLE, THEREFORE NO DEVICE OR RECORD RESEARCH EVAL COULD BE PERFORMED. THE PT'S PROGNOSIS WAS REPORTED AS GOOD. A FINAL F/U EXAM IS CURRENTLY SCHEDULED FOR 2006. CORRECTIVE/PREVENTATIVE ACTION: GIVEN THE ABSENCE OF KEY PRODUCT INPUT OR ANY OTHER INFO THAT WOULD SUGGEST A SPECIFIC DEFICIENCY IN THE IMPLANT, NO CORRECTIVE ACTION OR PREVENTIVE ACTIONS ARE BEING PRESCRIBED AT THIS TIME. RISK ASSESSMENT: THE DOCUMENTED SUCCESS RATE OF THE MBA, COMBINED WITH THE ABSENCE OF ANY VERIFIED DEFECTIVE IMPLANTS REPORTED TO DATE VALIDATES THE KMI SUBTALAR MBA'S SAFETY, EFFECTIVENESS AND ACCEPTABLE ASSOCIATED RISK LEVELS. LESS THAN 0.5% OF THE 14,000+ SUBTALAR MBA'S IMPLANTED TO DATE HAVE BEEN EXPLANTED , 99+% OF WHICH WERE PERFORMED AFTER COMPLETING PERMANENT CORRECTION OF THE PT'S HYPERPRONATED FOOT CONDITION AS THE DEVICE WAS DESIGNED TO DO. POST-MARKET SURVEILLANCE: POST MARKET SURVEILLANCE OF THE SUBTALAR MBA SYSTEM WILL CONTINUE. ALL SOURCES AND TYPES OF PRODUCT INFO WILL BE TAKEN INTO CONSIDERATION, REVIEWED BY KMI MANAGEMENT PER QSP-157, AND WILL BE EMPLOYED TO FACILITATE INCREMENTAL INPROVEMENTS IF DEEMED APPROPRIATE AND TO ENSURE THE CONTINUED SAFETY AND EFFICACY OF THIS IMPLANT SYSTEM.

    Description of Event or Problem · 1

    ON AUG 2, 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHOPEDIC FOOT IMPLANT TO ADDRESS PAIN REPORTED BY THE 67 YR-OLD FEMALE PT 22 MOS FOLLOWING THE ORIGINAL IMPLANT DATE. THE ATTENDING PHYSICIAN WAS CONTACTED FOR PARTICULARS. THE DEVICE WAS NOT RETURNED TO KMI FOR EVAL. AN INVESTIGATION WAS INITIATED AND IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-01XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other