BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR JTS IMPLANT

    MDR report key: 4365003 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00107
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    August 30, 2012
    Report Date
    August 8, 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

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE, A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. CURRENTLY 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 THE METS MODULAR DISTAL FEMUR IMPLANT (K121056).

    Additional Manufacturer Narrative · 1

    A REBUSH PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. BASED ON A REVIEW OF THE PATIENT'S X-RAYS THE REPORTED CIRCLIP ISSUE WAS CONFIRMED. THERE IS NO INDICATION THAT THE OBSERVED CIRCLIP ISSUE WAS DEVICE RELATED AS NO DEVICE OR MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. THE REPORTED CIRCLIP ISSUE COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS, DISEASE PROGRESSION OR SKELETAL MATURITY AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE CIRCLIP AND AXLE BACKING OUT OF THEIR POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE CIRCLIP AND AXLE BACKING OUT OF THEIR POSITION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00107 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839299 DISTAL FEMUR JTS IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME14836

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other