BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 4360974 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00085
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    July 4, 2012
    Report Date
    April 24, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. 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 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, PRE- AND POST-OPERATIVE 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. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. CORRECTED DATA: PRODUCT PROBLEM CORRECTED TO ADVERSE EVENT, CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT CORRECTED TO DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG), DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NONINVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2007 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS JAMMING AND PROVIDING NO FURTHER EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NON-INVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2007 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS JAMMING AND PROVIDING NO FURTHER EXTENSION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00085 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837968 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME13258

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention