BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCE TIBIAL STEM CANAL

    MDR report key: 5501238 · Received September 1, 2005

    Report

    Report Number
    1043534-2005-00110
    Event Type
    Other
    Date Received
    September 1, 2005
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. ADDITIONAL INFO HAS BEEN INCLUDED IN THE EVENT DESCRIPTION. HOSPITAL HAS ADVISED THAT PRODUCT WILL NOT BE RETURNED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. THE FOLLOWING DATES ARE ESTIMATED.

    Description of Event or Problem · 1

    ALLEGEDLY PT FRACTURED HIS TIBIA JUST BELOW THE TIP OF THE TIBIAL STEM. SURGEON REQUESTED A CUSTOMER, LONG STEM TO STABILIZE THE FRACTURE AND PROVIDE GOOD TIBIAL COMPONENT FIXATION. THE ORIGINAL SURGERY WAS (B)(6) 2001 WHERE THE STEM WAS IMPLANTED. IN (B)(6) 2004, THE PT FELL AND FRACTURED HER TIBIA BLOW THE STEM. A CABLE WAS UTILIZED BUT A NON-UNION PRESENTED. ON (B)(6) 2005, THE STEM WAS REVISED DUE TO THE NON-UNION. AT THE TIME OF THE REMOVAL (THAT WAS RELATED TO THE NON-UNION AND NOT TO OUR PRODUCT) IT WAS NOTED THAT THE STEM BECAME DETACHED OR DISASSOCIATED AS IT WAS BEING REMOVED FROM THE BONE. THE HOSPITAL IS REPORTING THIS DETACHMENT AS THEY WANTED TO NOTIFY US OF THIS OCCURRENCE. TO DATE, THIS PT STILL HAS SOME SORENESS AND SHOWS SOME SIGNS OF ARTHRITIS. UF MEDSUN #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE TIBIAL STEM CANAL KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1