BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4361014 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00079
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    April 30, 2012
    Report Date
    April 16, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DETAILS PROVIDED CONFIRM THAT THE PATIENT UNDERWENT THE INITIAL PROCEDURE TO IMPLANT THE GROWING PROSTHESIS ON (B)(6) 2007. SUBSEQUENTLY THE PATIENT WAS SCHEDULED A NUMBER OF FOLLOW-UP APPOINTMENTS TO GRADUALLY EXTEND THE PROSTHESIS TO LENGTHEN THE LEG. THE PATIENT FAILED TO ATTEND THESE FOLLOW-UP APPOINTMENTS AND AT THE TIME OF THE FRACTURE THERE WAS A 5CM DIFFERENCE IN THE LEG LENGTHS. IT IS POSSIBLE THAT THIS EXTEND TIME PERIOD WITH DIFFERENT LEG LENGTHS HAS CREATED A LARGER LOAD THAN EXPECTED ON THE PROSTHESIS, WHICH MAY HAVE CONTRIBUTED TO THE FRACTURE. HOWEVER, THE DEVICE WAS NOT RETURNED, SO THIS CANNOT BE CONFIRMED WITH THE CURRENT AVAILABLE INFORMATION. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED WITH NO NON-CONFORMANCES. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT REVISION OF THE DISTAL FEMUR JTS. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. HOWEVER THE DEVICE WAS IN-SITU FOR OVER 4 YEARS AND THE OBSERVED FRACTURE COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS OR DISEASE PROGRESSION AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE COMPLAINT IS BEING CLOSED AND TRACKED AND TRENDED. COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "DISTAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM/KRO".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CUSTOM JTS GROWER DISTAL FEMUR REPLACEMENT PROCEDURE IN (B)(6) 2007 AND SUBSEQUENTLY WAS REVISED IN (B)(6) 2012 DUE TO A FRACTURE OF THE IMPLANT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00079 ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A CUSTOM JTS GROWER DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2007 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO A FRACTURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837626 CUSTOM JTS NON-INVASIVE DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME13465

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention