BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS MODULAR DISTAL FEMUR IMPLANT

    MDR report key: 5086426 · Received September 16, 2015

    Report

    Report Number
    3004105610-2015-00079
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 27, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PERTAINING TO THE REPORTED EVENT, INCLUDING DETAILED INFORMATION REGARDING THE PATIENT'S REPORTED (B)(6) 2015 FALL, AND THE DEVICE PART NUMBER HAVE BEEN REQUESTED. THE COMPANY HAS ALSO REQUESTED RETURN OF THE DEVICE FOR EVALUATION, FOLLOWING THE REVISION SCHEDULED FOR (B)(6) 2015. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT WAS SUFFERING ASEPTIC LOOSENING FOLLOWING A FALL IN (B)(6) 2015. THE SURGEON HAS REQUESTED A LONGER, CUSTOM CEMENTED STEM AND WILL USE METS FEMORAL COMPONENTS FOR THE REVISION. THE REVISION IS DUE TO BE CARRIED OUT IN (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611448 METS MODULAR DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR