BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 5063881 · Received May 15, 2015

    Report

    Report Number
    3004105610-2015-00042
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY AND LABELING RECORDS CONFIRM THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS IDENTIFIED. FURTHER INFORMATION HAS 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

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A JTS DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2014. THE PATIENT UNDERWENT AN X-RAY WHICH CONFIRMED THAT THE UNCEMENTED FEMORAL STEM IS LOOSE AND IS EFFECTING THE PATIENT'S ABILITY TO WALK. A REVISION PROCEDURE IS SCHEDULED FOR LATE (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320920 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT LWJ STANMORE IMPLANTS WORLDWIDE LTD. BME 18757 BME 18757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention