BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4373029 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00188
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE TIBIAL BEARING WAS NOT SPECIFIED AS REQUIRED DURING THE DESIGN PROPOSAL, HOWEVER, GENERAL PRACTICE IS TO REPLACE THE COMPONENT SO A BEARING WAS SENT AS A MATTER OF COURSE. IN THIS INSTANCE THE SIZING WAS INCORRECT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A JTS PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE IT WAS DETERMINED THAT THE TIBIAL BEARINGS SENT WITH THE IMPLANT WERE THE WRONG SIZE. LONG BEARINGS WERE SENT INSTEAD OF SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850787 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18426

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention