BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 4071564 · Received August 28, 2014

    Report

    Report Number
    3004105610-2014-00018
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    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

    THE EXPLANTED DEVICE HAS BEEN REQUESTED TO BE RETURNED TO STANMORE IMPLANTS WORLDWIDE FOR EVALUATION. THE MANUFACTURING RECORDS HAVE BEEN INSPECTED AND NO NON-CONFORMANCE HAS BEEN IDENTIFIED. THE INVESTIGATION IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PASSIVE TIBIAL COMPONENT AND BUMPER PAD WERE RETURNED FOR EVALUATION. THE PRELIMINARY EVALUATION OF THE TIBIAL COMPONENT REVEALED A FAILURE SURFACE WHICH IS TYPICAL OF A BRITTLE FRACTURE ASSOCIATED WITH THE CASTING MATERIAL. FURTHER EVALUATION OF THE CASTING MATERIAL IS PENDING. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAD REACHED MAXIMUM EXTENSION BUT HAD BEEN LEFT IN PLACE. THE PATIENT WAS SKELETALLY MATURE AT THE TIME THE DEVICE FRACTURE OCCURRED. PATIENT ACTIVITY LEVELS WERE NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE LTD. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A METS DISTAL FEMUR WITH NO REPORTED COMPLICATIONS. THE RETURNED DEVICE WAS SENT FOR FURTHER EXTERNAL ANALYSIS AT THE (B)(6). THE EXPLANT WAS TESTED USING A SCANNING ELECTRON MICROSCOPE (SEM) AND RAMAN SPECTROSCOPY. THIS ADDITIONAL EVALUATION DID NOT REVEAL ANY FURTHER INFORMATION. THE TESTING CONCLUDED THAT THE EXPLANT SURFACE IS TYPICAL OF A BRITTLE FRACTURE ASSOCIATED WITH THE CAST MATERIAL. THE SOURCE OF THE FAILURE APPEARS TO ORIGINATE FROM AN AREA OF HIGH BENDING STRESS, PARTICULARLY WITH THE LONG STEM OF THIS IMPLANT. THERE IS NO INFORMATION AVAILABLE REGARDING THE PATIENT'S ACTIVITY LEVELS. BASED UPON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE COMPLAINT IS BEING CLOSED, AND IS TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00018. (B)(4).

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00018 ((B)(4)). THE PATIENT WAS ORIGINALLY DIAGNOSED WITH OSTEOSARCOMA IN THE RIGHT DISTAL FEMUR IN 2008. THE PATIENT WAS IMPLANTED WITH A STANMORE IMPLANTS DISTAL FEMUR JTS IMPLANT. IN AN EMAIL DATED JULY 31,2014, THE SURGEON ADVISED STANMORE IMPLANTS WORLDWIDE THAT THE PATIENT HAD A FRACTURE OF HER TIBIAL COMPONENT AND THUS REQUIRED A REVISION. THE FRACTURE WAS CONFIRMED VIA A PATIENT X-RAY PROVIDED BY THE FACILITY. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION ON (B)(6)2014, WITH A METS DISTAL FEMUR IMPLANT K121029 WITHOUT INCIDENT.

    Description of Event or Problem · 1

    THE PATIENT WAS ORIGINALLY DIAGNOSED WITH OSTEOSARCOMA IN THE RIGHT DISTAL FEMUR IN 2008. THE PATIENT WAS IMPLANTED WITH A STANMORE IMPLANTS CUSTOMER DEVICE IN (B)(6) 2008. IN AN EMAIL DATED (B)(6) 2014, THE SURGEON ADVISED STANMORE IMPLANTS WORLDWIDE THAT THE PATIENT HAD A FRACTURE OF HER TIBIAL COMPONENT AND THUS REQUIRED A REVISION. THE FRACTURE WAS CONFIRMED VIA A PATIENT X-RAY PROVIDED BY THE FACILITY. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION ON (B)(6) 2014, WITH A METS DISTAL FEMUR IMPLANT K121029 WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525079 DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME13576 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization