BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL IMPLANT

    MDR report key: 4373461 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00116
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 25, 2014
    Report Date
    November 25, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON HAD ORDERED A LONG TIBIAL COMPONENT, WHICH HE ACKNOWLEDGED AND APPROVED. STANMORE BELIEVES THE SURGEON HAD MISTAKENLY EXPECTED THE CUSTOM TIBIAL COMPONENT WOULD BE EQUIVALENT TO A METS MODULAR DISTAL FEMUR TIBIAL COMPONENT. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS REPORTED. THIS COMPLAINT IS BEING TRACKED AND TRENDED. THIS COMPLAINT IS BEING CLOSED.

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION OF THE COMPLAINT CONFIRMS THAT THE SURGEON ORDERED AND APPROVED A CUSTOM IMPLANT DESIGN WHICH INCLUDED A "STANDARD LONG TIBIAL COMPONENT". THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN FURTHER INFORMATION IS AVAILABLE. PLEASE NOTE THAT THIS CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121056).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A (B)(6) 2014 CUSTOM IMPLANT PROCEDURE, THE SURGEON WAS DISSATISFIED WITH THE "STANDARD LONG POLY ROTATING METAL COMPONENT". THE SURGEON REPORTED THAT THIS COMPONENT WAS "DIFFERENT" FROM THE POLY ROTATING METAL COMPONENT PROVIDED BY THE COMPANY IN HIS PREVIOUS CUSTOM IMPLANT CASE. THE IMPLANT PROCEDURE WAS SUCCESSFUL WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847487 CUSTOM DISTAL FEMORAL IMPLANT PROSTHESIS, KNEE, FEMOROTIBIAL, CONS KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18936

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other