BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4412123 · Received January 8, 2015

    Report

    Report Number
    3004105610-2015-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT NO NON-CONFORMITIES WERE IDENTIFIED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND AS A RESULT NO FURTHER ASSESSMENT OF THE DEVICE CAN BE PERFORMED. PLEASE NOTE THAT THE CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR (K121056).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A SURGEON STATING THAT DURING A PROCEDURE TO REVISE A CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 2011. DURING THE PROCEDURE THE DISTAL STEM COMPONENT CAME LOOSE AND HAD TO BE RE-IMPLANTED. THE SURGEON STATED THAT THIS WAS NOT THE FAULT OF THE DEVICE, BUT DURING THE INITIAL DISLOCATION OF THE HIP, THE SURGEON HAD TO USE A GREAT DEAL OF FORCE WHICH ULTIMATELY CAUSED THE STEM TO COME LOOSE. WHEN THE NEW PROXIMAL COMPONENT WAS PLACED TI DID NOT FULLY SEAT ON THE DISTAL STEM. A DELAY OF 90 MINUTES OCCURRED AS A RESULT OF BOTH EVENTS. IMPLANT WAS EVENTUALLY SEATED BUT WITH A SMALL GAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19109 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT PROSTHESIS, KNEE, FEMOROTIBIAL, CONS JWH STANMORE IMPLANTS WORLDWIDE LTD. BME18954

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other