BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 4535937 · Received February 11, 2015

    Report

    Report Number
    3004105610-2015-00011
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 2015
    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

    THE DEVICE WAS SECURELY IN PLACE THUS IT WAS DETERMINED TO LEAVE IT IN-SITU. THE SURGEON INDICATED THAT HE COULD NOT LOCK THE IMPLANT, HOWEVER IT WAS NOT CLEAR AS TO THE ROOT CAUSE. IT WAS AGREED THAT THE "C" COLLARS WERE THE APPROPRIATE ALTERNATIVE. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 WITH NO REPORTED COMPLICATIONS. AS THERE WERE NO PRODUCTS RETURNS A DEFINITIVE ROOT CAUSE COULD NOT BE ASSIGNED. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE HAS BEEN SCHEDULED FOR (B)(6) 2015. THE DEVICE WILL NOT BE RETURNED AS THE SURGEON WILL EXTEND THE DEVICE AND USE "C" COLLARS TO ACHIEVE THE REQUIRED EXTENSION. A FINAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE REVISION PROCEDURE. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA EMAIL DATED (B)(6) 2015 THAT HIS PATIENT'S IMPLANT EXTENSION MECHANISM SEEMS TO HAVE JAMMED AND THE ATTEMPT TO LENGTHEN THE IMPLANT ON (B)(6) 2014 WAS UNSUCCESSFUL. THE PATIENT HAS A LEG LENGTH DISCREPANCY OF ABOUT 2 CM. AS THE IMPLANT IS WELL FIXED, THE SURGEON HAS REQUESTED A "C" COLLAR FOR A REVISION PROCEDURE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00011 (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA EMAIL DATED (B)(6) 2015 THAT HIS PATIENT'S IMPLANT EXTENSION MECHANISM SEEMS TO HAVE JAMMED AND THE ATTEMPT TO LENGTHEN THE IMPLANT ON (B)(6) 2014 WAS UNSUCCESSFUL. THE PT HAS A LEG LENGTH DISCREPANCY OF ABOUT 2 CM. AS THE IMPLANT IS WELL FIXED, THE SURGEON HAS REQUESTED A "C" COLLAR FOR A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100089 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BNE18011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention