BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 4315372 · Received November 14, 2014

    Report

    Report Number
    3004105610-2014-00048
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COLLAPSE OF THE MIG DEVICE WAS NOT CONFIRMED AS NO SEQUENTIAL X-RAYS WERE PROVIDED. THERE IS NO INDICATION THAT THE REPORTED MIG COLLAPSE WAS DEVICE RELATED AS NO DEVICE OR MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. THE REPORTED MIG COLLAPSE COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS OR SKELETAL MATURITY AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). FURTHER INFORMATION SUCH AS PRODUCT DETAILS, PRODUCT RETURN, SEQUENTIAL X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA - CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT CORRECTED TO DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG). LIMB SALVAGING SYSTEM CORRECTED TO LIMB SALVAGE SYSTEM. EXPIRATION DATE CORRECTED FROM 03/27/2005 TO 03/19/2005. OPERATOR OF DEVICE CORRECTED FROM HEALTH PROFESSIONAL TO PATIENT.

    Additional Manufacturer Narrative · 1

    THE 2004 DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND. THE PLANNED MID- NOVEMBER REVISION PROCEDURE INCLUDES EXTENDING THE PROSTHESIS, INTRODUCING COLLARS TO THE EXTENDED GAP, REPLACING THE CURRENT TIBIAL COMPONENTS WITH A METS COMPONENT AND REPLACING THE AXLE/CIRCLIP/PLASTIC PARTS. AN APPROVED DESIGN WAS MANUFACTURED AND DISPATCHED TO THE FACILITY. FOLLOW UP INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON RECEIPT OF ADDITIONAL INFORMATION. THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    THE (B)(6) DISTRIBUTOR REPORTED THAT THE PATIENT REQUIRES REPLACEMENT OF THE TIBIAL COMPONENT, ALONG WITH THE BUSHES. IN (B)(6) 2004, THIS PATIENT RECEIVED A CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT, AND THEN IN 2006, UNDERWENT A LEG LENGTHENING. BASED UPON THE PATIENT'S RECENT X-RAYS, THE SURGEON IS QUESTIONING THE EXTENT OF THE PATIENT'S CURRENT PROSTHESIS GAP. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00048 ((B)(4)).

    Description of Event or Problem · 1

    THE AUSTRALIAN DISTRIBUTOR REPORTED THAT THE PATIENT REQUIRES REPLACEMENT OF THE TIBIAL COMPONENT, ALONG WITH THE BUSHES. IN (B)(6) 2014, THIS PATIENT RECEIVED A CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT, AND THEN IN 2006, UNDERWENT A LEG LENGTHENING. BASED UPON THE PATIENT'S RECENT X-RAYS, THE SURGEON IS QUESTIONING THE EXTENT OF THE PATIENT'S CURRENT PROSTHESIS GAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738839 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME10998 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other