BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4844448 · Received June 12, 2015

    Report

    Report Number
    3004105610-2015-00052
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    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

    A REVIEW OF THE MFG HISTORY RECORDS CONFIRMS THAT THE DEVICE WAS MFR TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. THIS PT HAD A "MARK 4" TIBIAL COMPONENT IN SITU. THE REPLACEMENT COMPONENT WHICH WAS PROVIDED BUT NOT IMPLANTED, WAS ALSO A "MARK 4." THE REPLACEMENT COMPONENT HAS BEEN RETURNED TO THE COMPANY AND IS CURRENTLY UNDERGOING AN INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    DURING A REVISION PROCEDURE (B)(4), THE SURGEON REPORTED TO THE SALES REP THAT WHEN HE INSERTED THE NEW TIBIAL BEARING INTO THE RETAINED METAL CASED TIBIA, IT WOULD NOT FULLY ENGAGE. THE SURGEON REPORTED THAT THE NEW TIBIAL APPEARED TO BE SLIGHTLY LONGER THAN THE TIBIAL BEARING IN-SITU. THE SURGEON COMPLETED THE PROCEDURE BY RE-IMPLANTING THE ORIGINAL TIBIAL BEARING. NO PT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384193 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 19432 BME 19432

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other