BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 6127165 · Received November 25, 2016

    Report

    Report Number
    3004105610-2016-00027
    Event Type
    Injury
    Date Received
    November 25, 2016
    Report Date
    March 14, 2016
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAS REQUESTED A REPLACEMENT NON INVASIVE GROWER DISTAL FEMUR PROSTHESIS IN ORDER TO GIVE THE PATIENT MORE LENGTHENING POTENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778466 DISTAL FEMUR JTS PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 17362

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R