BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTIM POROUS TOTAL CONDYLAR FEMORAL

    MDR report key: 1052787 · Received May 20, 2008

    Report

    Report Number
    1043534-2008-00105
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K930188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00104. THIS EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY, PT REPORTED HAVING A HEAVY FALL SOME TIME PREVIOUSLY ON HER RIGHT KNEE. IT APPEARS THIS RESULTED IN A FRACTURE OF THE MEDIAL CONDYLE OF THE IMPLANT AND THE PT'S FEMUR. AT THE TIME OF THE REVISION, THE FRACTURE HAD ACTUALLY HEALED. FEMORAL COMPONENT REMOVED WITHOUT TOO MUCH DIFFICULTY. REPLACED WITH A PRIMARY COMPONENT. INSERT DAMAGED FROM THE BROKEN FEMORAL COMPONENT, SO ALSO EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTIM POROUS TOTAL CONDYLAR FEMORAL JWH WRIGHT MEDICAL TECHNOLOGY, INC. 049A092292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R