BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS DISTAL FEMUR IMPLANT

    MDR report key: 5235537 · Received November 19, 2015

    Report

    Report Number
    3004105610-2015-00113
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STANMORE IMPLANTS WORLDWIDE LTD (SIW) WAS NOTIFIED AFTER THE REVISION OF A CUSTOM DEVICE TO AN "OFF THE SHELF" DEVICE. THE REPORTED FRACTURE HAS NOT BEEN CONFIRMED BY SIW. THE EXPLANTED DEVICE WAS NOT RETURNED TO SIW FOR EVALUATION. THEREFORE, BASED UPON THE INFORMATION REPORTED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PATIENT UNDERWENT A SUCCESSFUL REVISION WITH A METS DISTAL FEMUR IMPLANT WITHOUT INCIDENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY OF THE DEVICE HAS BEEN REVIEWED AND CONFIRMED THAT NO ABNORMALITIES OR DEVIATIONS WERE REPORTED. THIS COMPLAINT IS BEING INVESTIGATED AND THE RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS STANDING AND ON TURNING THE PROSTHESIS SHAFT BROKE AT THE JUNCTION OF THE COLLAR AND STEM; THUS REQUIRING AN URGENT REVISION. THE DEVICE WAS REPLACED WITH A METS DISTAL FEMUR REPLACEMENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765127 CUSTOM JTS DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME 15789 BME 15789

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention