BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEMUR JTS

    MDR report key: 6095364 · Received November 11, 2016

    Report

    Report Number
    3004105610-2016-00112
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASSESSMENT OF THE RETURNED DEVICE INDICATES THAT THE OPEN END OF THE KEYWAY OF THE REVISION INNER SHAFT HAD BEEN DAMAGED TO THE EXTENT THAT THE KEYWAY IS OUT OF SPECIFICATION AND WOULD THEREFORE NO LONGER BE EXPECTED TO FIT INTO THE OUTER CYLINDER OF THE IN SITU JTS IMPLANT. IT CANNOT BE DETERMINED HOW THE DEVICE BECAME DAMAGED BUT INVESTIGATION INDICATES THE DAMAGE HAS BEEN CAUSED TO THE KEYWAY FOLLOWING RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE IMPLANT DID NOT FIT SO THE ORIGINAL DEVICE WAS RE-IMPLANTED AND THE PATIENT NEEDS TO BE OPERATED ON AGAIN. THE DATE FOR THE REVISION SURGERY IS NOT YET KNOWN. THE RETURNED DEVICE REMAINS UNDER INVESTIGATION AT THIS TIME. TESTING IS ONGOING TO DETERMINE THE ROOT CAUSE. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT DID NOT FIT THE PATIENT, THE JTS INNER PISTON SUPPLIED WOULD NOT SLIDE INTO THE JTS OUTER BODY. THE SURGEON FELT THAT THE ANTI-ROTATION GROOVE WAS EITHER TOO NARROW OR TOO SHALLOW TO FIT WITH THE ANTI-ROTATION PIN IN THE OUTER BODY. THIS IS A SUPPLEMENTAL REPORT TO MFR REPORT NUMBER 2004105610-2016-00112, REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT DID NOT FIT THE PATIENT, THE JTS INNER PISTON SUPPLIED WOULD NOT SLIDE INTO THE JTS OUTER BODY. THE SURGEON FELT THAT THE ANTI-ROTATION GROOVE WAS EITHER TOO NARROW OR TOO SHALLOW TO FIT WITH THE ANTI-ROTATION PIN IN THE OUTER BODY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747484 PROXIMAL FEMUR JTS LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD PIN 20348 PIN 20348

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention