BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    MDR report key: 4004697 · Received July 24, 2014

    Report

    Report Number
    3004105610-2014-00014
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE PROVIDED X-RAY INFORMATION, THE REPORTED LOOSENING OF THE FEMORAL STEM WAS NOT CONFIRMED AS THE PROSTHESIS HAD BEEN REMOVED. THERE IS NO INDICATION THAT THE REPORTED LOOSENING WAS DEVICE RELATED AS NO DEVICE OR MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. THE REPORTED LOOSENING COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS, DISEASE PROGRESSION OR SKELETAL MATURITY AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION AND PRODUCT RETURN WERE REQUESTED HOWEVER IT WAS NOT PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE IMPLANTS WORLDWIDE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA: PATIENT IDENTIFIER WAS CORRECTED FROM (B)(6). BRAND NAME WAS CORRECTED FROM "JTS NON-INVASIVE EXTENDABLE DISTAL FEMUR REPLACEMENT" TO "JTS EXTENDIBLE DISTAL FEMORAL IMPLANT ". COMMON DEVICE NAME WAS CORRECTED FROM "DISTAL FEMUR EXTENDABLE IMPLANT" TO "LIMB SALVAGE SYSTEM". EXPIRY DATE WAS CORRECTED FROM 03/24/2013 TO 03/25/2013. THE 510(K) # WAS CORRECTED FROM K092138 TO K133152.

    Additional Manufacturer Narrative · 1

    THE SURGEON CONFIRMED THAT THE REASON FOR THE PT'S REVISION AFTER 18 MONTHS WAS DUE TO ASEPTIC LOOSENING. ASEPTIC LOOSENING IS A PRINCIPAL MODE OF FAILURE OF THE CEMENTED STEM FIXATION IN MASSIVE IMPLANTS (BLUNN ET AL. 2000) IN PARTICULAR DISTAL FEMORAL REPLACEMENTS ( P S UNWIN, COBB, AND WALKER 1993). OVER THE YEARS, CHANGES TO THE DESIGN OF CONVENTIONAL IMPLANTS SUCH AS THE INTRODUCTION OF A GROOVED HYDROXYAPATITE *HA) COLLAR AT THE SHOULDER OF THE IMPLANT, AND USE OF A ROTATING HINGE KNEE INSTEAD OF A FIXED HINGE KNEE DESIGN, HAVE REDUCED THE RISK OF ASEPTIC LOOSENING DRAMATICALLY (MYERS ET AL. 2007A; MYERS ET AL. 2007B). VARIABLE REVISION RATES FOR CUSTOM DISTAL FEMORAL REPLACEMENTS WITH A ROTATING HINGE KNEE HAVE BEEN REPORTED (5% TO 33%) (MELANIE JEAN COATHUP AL. 2013; P S UNWIN, COBB, AND WALKER 1993; MARUTHAINAR ET AL. 2006; MYERS ET AL. 2007A).

    Description of Event or Problem · 1

    IN AN EMAIL DATED (B)(6) 2014, THE STANMORE IMPLANTS SALES REP RECEIVED A "PT PRESCRIPTION FORM" WITH THE CLINICIANS' COMMENTS THAT THE PT'S IMPLANT WAS LOOSE AND REMOVED. SHE NOW NEEDS A REPLACEMENT. A REVISION IMPLANT WAS PROVIDED FOR A PROCEDURE SCHEDULED ON (B)(6) 2014. THE CLINICIAN CONCLUDED THAT "THE TISSUE WAS NEVER FOUND TO BE INFECTED" I.E., THE CAUSE OF FAILURE WAS ASEPTIC LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN EMAIL DATED (B)(6) 2014 THAT THE STANMORE IMPLANTS SALES REPRESENTATIVE RECEIVED A "PATIENT PRESCRIPTION FORM" WITH THE CLINICIANS' COMMENTS THAT THE PATIENT'S IMPLANT WAS LOOSE AND REMOVED, SHE NOW NEEDS A REPLACEMENT. A REVISION IMPLANT WAS PROVIDED FOR A PROCEDURE SCHEDULED ON (B)(6) 2014. THE CLINICIAN CONCLUDED THAT "THE TISSUE WAS NEVER FOUND TO BE INFECTED". THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00014 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435420 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME17374

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other