BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4360985 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00082
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    April 10, 2012
    Report Date
    April 16, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REPRESENTATIVE FROM STANMORE IMPLANTS WORLDWIDE ATTENDED THE PROCEDURE AND CONFIRMED THE COMPLAINT THAT WAS REPORTED. DISCUSSION WITH THE SURGEON FOLLOWING THE PROCEDURE CONCLUDED THAT THE PATIENT IS HIGHLY ACTIVE AND AS A RESULT HAS LIKELY EXPOSED THE PROSTHESIS ALREADY IMPLANTED TO HIGH BENDING FORCES WHICH WOULD HAVE GONE THROUGH THE INNER SHAFT, POSSIBLY CAUSING THE DIFFICULTY EXPERIENCED DURING THE PROCEDURE. A REVIEW OF THE MANUFACTURING RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED WITH NO NON-CONFORMANCES. IT IS NOT POSSIBLE TO EVALUATE THE DEVICES AS THEY REMAIN IMPLANTED. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE CURRENT AVAILABLE INFORMATION. INVESTIGATION CONCLUDED THAT THIS IS AN ISOLATED EVENT. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Additional Manufacturer Narrative · 1

    THE REVIEW ON THE PROVIDED INFORMATION CONCLUDED THAT THE REPORTED ASSEMBLY ISSUE OF A DISTAL FEMORAL JTS DEVICE WAS NOT CONFIRMED. THERE IS NO INDICATION THAT THE REPORTED ASSEMBLY ISSUE WAS DEVICE RELATED AS NO DEVICE MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. IT IS NOTED THAT THE ALREADY IS SITU DISTAL FEMORAL INNER SHAFT MAY HAVE BECOME DAMAGED OVER TIME. THEREFORE, THE REPORTED ASSEMBLY ISSUE COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY OR ACTIVITY LEVELS AS IS REPORTED IN THIS EVENT, AND /OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. 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 REMAINS IMPLANTED AND THE REPORTED ASSEMBLY ISSUE COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS AS IS REPORTED IN THIS EVENT 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. CORRECTED DATA: DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON DURING THE PROCEDURE THAT HE WAS EXPERIENCING DIFFICULTIES PLACING THE NEW DISTAL SECTION OF THE IMPLANT OVER THE PROXIMAL SECTION WAS SITTING 30MM FROM BEING FLUSH. THE SURGEON HAD TO USE ADDITIONAL FORCE TO SEAT THE COMPONENT FLUSH AGAINST THE EXISTING COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON DURING THE PROCEDURE THAT HE WAS EXPERIENCING DIFFICULTIES PLACING THE NEW DISTAL SECTION OF THE IMPLANT OVER THE OLD PROXIMAL SECTION. THE NEW DISTAL SECTION WAS SITTING 30MM FROM BEING FLUSH. THE SURGEON HAD TO USE ADDITIONAL FORCE TO SEAT THE COMPONENT FLUSH AGAINST THE EXISTING COMPONENT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00082 (SIW-(B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837754 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME16985

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention