BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR

    MDR report key: 4858606 · Received June 16, 2015

    Report

    Report Number
    3004105610-2015-00054
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED IMPLANT FRACTURE INVOLVING A DISTAL FEMUR JTS WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH X-RAY REVIEW. DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION WITH NO RELEVANT REPORTED DISCREPANCIES. THE PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY RESULTING IN THE IMPLANTATION OF A NEW TIBIAL COMPONENT. THE FRACTURED TIBIAL STEM OF THE JTS DISTAL FEMUR WAS IN-SITU FOR 4 YEARS PRIOR TO THE NEED FOR REVISION. THE CAUSE OF THE FRACTURE WAS DETAILED BY THE SURGEON AS ASSOCIATED WITH A FALL THAT THE PATIENT INCURRED AT SCHOOL. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. CORRECTED DATA COMMON DEVICE NAME/PRODUCT CODE CORRECTED FROM "DISTAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM/KRO".

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG HISTORY RECORDS CONFIRM THAT THE DEVICE WAS MANUFACTURED TO SPEC WITH NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RADIOGRAPHS PROVIDED BY THE SURGEON CONFIRM THAT THE TIBIAL COMPONENT HAS FRACTURED. FURTHER INFO AND THE RETURN OF THE DEVICE HAVE BEEN REQUESTED AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    THE SURGEON HAS REPORTED THAT THE PT HAS FALLEN AND BROKEN THE TIBIAL COMPONENT OF THE CUSTOM JTS DISTAL FEMUR IMPLANT IN (B)(6) 2015. A NEW IMPLANT HAS BEEN REQUESTED IN ORDER TO CARRY OUT A REVISION PROCEDURE.

    Description of Event or Problem · 1

    THE SURGEON HAS REPORTED THAT THE PATIENT HAS FALLEN AND BROKEN THE TIBIAL COMPONENT OF THE CUSTOM JTS DISTAL FEMUR IMPLANT IN (B)(6) 2015. A NEW IMPLANT HAS BEEN REQUESTED IN ORDER TO CARRY OUT THE REVISION PROCEDURE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00054 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392576 CUSTOM JTS NON-INVASIVE DISTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME 16208 BME 16208

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention