BEUDAMED
    FDA Adverse Event Other Summary report: N

    K2 HEMI TOE IMPLANT SYSTEM

    MDR report key: 795565 · Received December 14, 2006

    Report

    Report Number
    2028840-2006-00024
    Event Type
    Other
    Date Received
    December 14, 2006
    Date of Event
    November 14, 2006
    Report Date
    December 12, 2006
    Manufacturer
    KINETIKOS MEDICAL INC.
    Product Code
    LZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ULTIMATELY DETERMINED THAT THIS PARTICULAR IMPLANT LOT, TECHNICALLY HAD AN ADDITIONAL 2 YEARS OF SHELF LIFE BEYOND ITS LABELING INDICATIONS, OWING TO TESTING PERFORMED DURING THE INTERVAL BETWEEN ITS PRODUCTION DATE (SEPTEMBER, 2003) AND ITS IMPLANT DATE. AS THIS PARTICULAR IMPLANT HAD NOT BEEN RETURNED TO KMI FROM FIELD CONSIGNMENT SINCE THIS TESTING WAS COMPLETED, IT WAS NEVER RE-LABELED WITH THE EXTENDED EXPIRATION DATING ALLOWED. THEREFORE, THERE IS NO CLINICAL IMPLICATION TO THE PATIENT OF ITS HAVING BEEN IMPLANTED. IDENTIFYING THE ROOT CAUSE - OWING TO UNFAMILIARITY WITH THE KINETIKOS MEDICAL PRODUCT LINES, THE K2 HEMI TOE INVENTORY WAS THE ONLY STERILE IMPLANT GROUP NOT ORIGINALLY PROGRAMMED IN THE DISTRIBUTION CENTERS' DATABASE AS BEING SHELF-LIFE SENSITIVE. PRODUCT FROM KMI'S WAREHOUSE AND FIELD CONSIGNMENT INVENTORY WITH LIMITED REMAINING SHELF LIFE HAD BEGUN TO BE SHIPPED TO AND STORED IN SEPTEMBER, 2006, AND WAS THEREFORE SUBJECT TO DISTRIBUTION AS NEEDED. CORRECTIVE/PREVENTATIVE ACTION - SINCE THE ADVENT OF THIS EVENT, TWO FIRST-LINE CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN PUT INTO PLACE WHICH WILL PRECLUDE A RECURRENCE OF THIS NATURE: THE SOURCE OF STERILE IMPLANTS HAS INVENTORIED ALL STERILE IMPLANTS (INCLUDING ALL K2 HEMI TOE), ISOLATED THOSE THAT WILL EXPIRE BY THE END OF FEBRUARY, 2007, AND QUARANTINED OR DESTROYED THEM. INVENTORYING AND PURGING OF ALL PRODUCTS DUE TO EXPIRE WITHIN THE NEXT 90 DAYS WILL BE PERFORMED AT KMI ON A ROLLING MONTHLY BASIS UNTIL THESE OPERATIONS PERMANENTLY MOVE OFF-SITE (CURRENTLY SCHEDULED FOR JANUARY, 2007). THE INVENTORY CONTROL SYSTEM AT THE DISTRIBUTION CENTER HAS NOW BEEN PROGRAMMED TO AUTOMATICALLY FLAG ANY INVENTORY DUE TO EXPIRE WITHIN THE NEXT 90 DAYS, INCLUDING K2 HEMI TOES. ONCE IDENTIFIED, THOSE MATERIALS WILL BE QUARANTINED BY QC PERSONNEL, AND RETURNED TO KINETIKOS MEDICAL, INC. FOR FINAL DISPOSITIONING. RISK ASSESSMENT - GIVEN THE SYSTEMIC CORRECTIVE AND PREVENTIVE ACTIONS THAT HAVE NOW BEEN IMPLEMENTED AT BOTH THE INVENTORY ORIGIN AND DISTRIBUTION CENTERS, THE RISK OF DISTRIBUTING ANY EXPIRED (ACTUAL, OR AS LABELED) STERILE IMPLANTS HAVE VIRTUALLY BEEN ELIMINATED. POST-MARKET SURVEILLANCE - OF THE 1,875+ K2 HEMI TOE IMPLANTS THAT HAVE BEEN IMPLANTED SINCE THIS PRODUCTS' INITIAL RELEASE IN 2002, THIS IS ONLY THE SECOND REPORTABLE INCIDENT ON RECORD, DEMONSTRATING THIS SYSTEMS RELIABILITY, SAFETY AND EFFECTIVENESS. POST-MARKET SURVEILLANCE OF THE K2 HEMI TOE SYSTEM IS ON-GOING; ALL SOURCES AND TYPES OF PRODUCT INFORMATION WILL BE TAKEN INTO CONSIDERATION, REVIEWED AND DOCUMENTED BY KMI MANAGEMENT PER QSP-157.

    Description of Event or Problem · 1

    EXPLANT OF A KATALYST RADIAL HEAD SYSTEM IMPLANT FROM THE PATIENT IMMEDIATELY (DURING ORIGINAL IMPLANTATION) UPON DETERMINING THAT THE IMPLANT'S EXPIRATION DATE HAD ELAPSED SIX WEEKS PREVIOUSLY. THE EXPLANTED COMPONENT WAS RETURNED TO KMI FOR EVALUATION ON DEC. 12, 2006. IN 2006, KINETIKOS MEDICAL, INC., WAS INFORMED OF A K2 HEMI TOE WITH EXPIRED LABELING THAT WAS INADVERTENTLY IMPLANTED INTO A PATIENT, THEN IMMEDIATELY REMOVED AND REPLACED (WITHIN MINUTES) WHEN THIS DISCOVERY WAS MADE. THE EXPLANTED DEVICE WAS RETURNED TO KMI ON DEC. 12, 2007 FOR CONFIRMATION OF LOT NUMBER AND EXPIRATION STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K2 HEMI TOE IMPLANT SYSTEM ORTHOPEDIC TOE IMPLANT LZJ KINETIKOS MEDICAL INC. 20-1020 7894-20-8224

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other