BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4185112 · Received October 13, 2014

    Report

    Report Number
    3004105610-2014-00031
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS UNDERGONE SUCCESSFUL SURGERY FOR A DISTAL FEMUR. THE SURGEON STATES THAT HE REMOVED 1 CM OF THE FEMORAL STEM DUE TO COMPLEX/DIFFICULT ANATOMICAL ISSUES THAT DID NOT SHOW UP ON X-RAYS. THERE WERE NO REPORTED COMPLICATIONS FROM THIS PROCEDURE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA - DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM. DEVICE MANUFACTURE DATE CORRECTED FROM 09/15/2014 TO 09/12/2014.

    Additional Manufacturer Narrative · 1

    THE DESIGN PROPOSAL FOR THE CUSTOM DEVICE WAS GENERATED AFTER REVIEWING THE PATENT'S X-RAYS. THE DESIGN PROPOSAL WAS SUBSEQUENTLY APPROVED BY THE SURGEON ON (B)(6) 2014. THE SURGEON REPORTED THAT THE PATIENT'S GENERAL ANATOMY AND SURROUNDING SOFT TISSUE (WHICH DOES NOT SHOW ON X-RAY) REQUIRED THAT THE DEVICE BE MODIFIED DURING THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED, THE DEVICE WAS MANUFACTURED PER THE DESIGN PROPOSAL AND NO NON CONFORMANCE WERE REVEALED. PLEASE NOTE THAT THIS CUSTOM DISTAL FEMUR DEVICE IS SIMILAR TO THE METS MODULAR DISTAL FEMUR K121029.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE ATTENDED A CUSTOMER NON-INVASION GROWER DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2014. IT WAS REPORTED THAT DURING THE OPERATION, THE SURGEON HAD TO CUT 1CM FROM THE END OF FEMORAL STEM TO SEAT THE IMPLANT AS A RESULT OF THE PATIENT'S "DIFFICULT/COMPLEX ANATOMY'. THE SURGERY WENT WELL AND THE SURGEON WAS SATISFIED WITH THE OUTCOME.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE ATTENDED A CUSTOMER NON-INVASIVE GROWER DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2014. IT WAS REPORTED THAT DURING THE OPERATION, THE SURGEON HAD TO CUT 1CM FROM THE END OF FEMORAL STEM TO SEAT THE IMPLANT AS A RESULT OF THE PATIENT'S "DIFFICULT/COMPLEX ANATOMY". THE SURGERY WENT WELL AND THE SURGEON WAS SATISFIED WITH THE OUTCOME. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00031 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645917 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME18887 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR