BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS DISTAL FEMUR REPLACEMENT

    MDR report key: 4898309 · Received July 1, 2015

    Report

    Report Number
    3004105610-2015-00060
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS A COMPLEX HISTORY FOLLOWING HER ORIGINAL IMPLANT IN 1996. THE COMPONENTS THAT ARE THE SUBJECT OF THIS REPORT WERE IMPLANTED IN 2006/2007 FOLLOWING THE USE OF A CEMENT SPACER TO TREAT AN INFECTION. RADIOGRAPHS HAVE BEEN REVIEWED AND CONFIRM THE REPORTED LOOSENING OF THE FEMORAL STEM. THE PATIENT UNDERWENT REVISION AND HAS BEEN SUCCESSFULLY IMPLANTED WITH A DISTAL FEMUR JTS TO REPLACE A FEMORAL STEM IMPLANTED 9 YEARS EARLIER. THE FEMORAL STEM FAILED DUE TO ASEPTIC LOOSENING. THIS COMPLAINT IS BEING TRACKED AND TRENDED. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS A COMPLEX HISTORY FOLLOWING HER ORIGINAL IMPLANT IN 1996. THE COMPONENTS THAT ARE THE SUBJECT OF THIS REPORT WERE IMPLANTED IN 2006/2007 FOLLOWING THE USE OF A CEMENT SPACER TO TREAT AN INFECTION. RADIOGRAPHS HAVE BEEN REVIEWED AND CONFIRM THE REPORTED LOOSENING OF THE FEMORAL STEM. ADDITIONAL INFORMATION PERTAINING TO THE PATIENT, EVENT, ITEM/BATCH NUMBERS, THE UPCOMING SURGERY DATE AND THE RETURN OF THE EXPLANTED DEVICE HAVE BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE SURGEON THAT THE PATIENT HAS A LOOSE FEMORAL STEM AND REQUIRES A REVISION PROCEDURE. THE PATIENT HAS HAD MULTIPLE SURGERIES: PATIENT UNDERWENT INITIAL PROCEDURE (B)(6) 1996. REVISED (B)(6) 2002 (FAILED PROSTHESIS). SPACER INSERTED (B)(6) 2006 (INFECTION). OPINION REQUESTED FOR CUSTOM DEVICE 2006 TO REPLACE THE TEMPORARY SPACER DEVICE. METS USED INSTEAD (NOW BEING REVISED AND SUBJECT OF THIS COMPLAINT. REBUSHING PROCEDURE (B)(6) 2008.

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED A NEW NON-INVASIVE GROWING PROSTHESIS TO CARRY OUT A REVISION PROCEDURE DUE TO A LOOSE FEMORAL STEM. THE REVISION PROCEDURE IS SCHEDULED TO TAKE PLACE IN MID (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426595 METS DISTAL FEMUR REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD MS S TM/ 10X150

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R