BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT FOR CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4373083 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00213
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    September 20, 2013
    Report Date
    September 20, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. 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 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO A MANUFACTURING ISSUE. ON INITIAL RECEIPT OF THE REPORTED EVENT, THE EVENT DESCRIPTION WAS REVIEWED AND WITH THE LIMITED INFORMATION AVAILABLE AT THAT TIME, A DECISION WAS MADE TO REPORT THE EVENT. HOWEVER ON COMPLETION OF THE INVESTIGATION INTO THE REPORTED EVENT IT CAN NOW BE CONCLUDED THAT THE INCIDENT DOES NOT MEET THE THREE BASIC REPORTING CRITERIA REFERENCED IN 21 CFR PART 803 AS A MARKETED DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR A MARKETED DEVICE HAS NOT MALFUNCTIONED WHERE THE MALFUNCTION OF THE DEVICE OR A SIMILAR MARKETED DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE JTS DRIVE UNIT WAS NOT WORKING AS IT SHOULD BE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE JTS DRIVE UNIT WAS NOT WORKING AS IT SHOULD BE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00213 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851459 JTS DRIVE UNIT FOR CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other