BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR, MIN-INVASIVE GROWER

    MDR report key: 4859433 · Received June 16, 2015

    Report

    Report Number
    3004105610-2015-00055
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON HAS ADVISED STANMORE IMPLANTS THAT THE PATIENT HAS DECIDED TO DEFER THE SURGERY, THUS NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. PLEASE NOTE THAT UPON FURTHER INVESTIGATION, IT WAS CONFIRMED THAT THE DEVICE WHICH IS THE SUBJECT OF THIS COMPLAINT IS A DISTAL FEMUR MINIMALLY INVASIVE GROWER IMPLANT. THE DISTAL FEMUR MINIMALLY INVASIVE GROWER IMPLANT IS NOT MARKETED IN THE US, NOR IS A SIMILAR DEVICE MARKETED IN THE US.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. THE COMPLAINT INVESTIGATION IS ONGOING; ADDITIONAL PATIENT AND EVENT SPECIFIC INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00055. ((B)(4))

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT HAD UNDERGONE A MINIMALLY INVASIVE EXTENDING DISTAL FEMUR REPLACEMENT PROCEDURE IN (B)(6) 2009. THE PROSTHESIS WAS SUBSEQUENTLY LENGTHENED SUCCESSFULLY 5 CM OVER 3 YEARS. THE SURGEON HAS REPORTED THAT THIS PROSTHESIS HAS COLLAPSED AND HAS REQUESTED C COLLARS IN ORDER TO RE-LENGTHEN THE COMPONENT TO THE REQUIRED SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392829 DISTAL FEMUR, MIN-INVASIVE GROWER CUSTOM DISTAL FEMUR KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 14607 BME 14607

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention