BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373396 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00128
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 24, 2012
    Report Date
    January 9, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. WHILST CEMENT CAN SOMETIMES ANCHOR THE POLY TO THE CUT TIBIA, IT IS IN FACT NOT NECESSARY. HISTORICALLY THE COMPONENT WAS NOT CEMENTED. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOMER IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PASSIVE TIBIAL REPLACEMENT ON (B)(6) 2012. HE NOTED THAT HE HAD DIFFICULTY FIXING THE TIBIAL COMPONENT WITH CEMENT TO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847321 CUSTOM DISTAL FEMUR IMPLANT CUSTOM DISTAL FEMUR KRO STANMORE IMPLANTS WORLDWIDE LTD. BME17579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other