BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4346734 · Received December 2, 2014

    Report

    Report Number
    3004105610-2014-00055
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    JWH
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. WE HAVE REQUESTED THAT THE SURGEON PROVIDE ADDITIONAL PATIENT INFORMATION AND THAT FOLLOWING THE REVISION SCHEDULED FOR (B)(6) 2014, HE RETURN THE EXPLANTED COMPONENTS FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED ONCE FURTHER INVESTIGATION INFORMATION IS AVAILABLE. PLEASE NOTE THAT THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT K121029.

    Additional Manufacturer Narrative · 1

    THE EXPLANT WAS DISCARDED, AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE PATIENT'S HISTORY IDENTIFIED THAT THE DEVICE WAS IMPLANTED FOR 16 YEARS, WHICH IS GREATER THAN THE LIFE EXPECTANCY OF THE DEVICE OF TEN YEARS; THE REBUSHING IS THEREFORE LIKELY DUE TO NORMAL WEAR AND TEAR.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00055 ((B)(4)).

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE COMPANY RECEIVED AN ORDER FROM THE SURGEON FOR A CUSTOM REPLACEMENT AXEL AND BUSHES FOR THE PATIENT'S "REBUSHING" REVISION SCHEDULED FOR (B)(6) 2014. THE PATIENT'S MEDICAL HISTORY INCLUDES DIAGNOSIS OF A BONE TUMOR IN 1986. AT THAT TIME, THE PATIENT RECEIVED A STANMORE IMPLANTS CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT AND THEN 12 YEARS LATER IN 1998, REPORTEDLY UNDERWENT A "REBUSHING" PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776053 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT PROSTHESIS, KNEE, FEMOROTIBIAL, CONS JWH STANMORE IMPLANTS WORLDWIDE LTD. BME968 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other