BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1020522 · Received March 28, 2008

    Report

    Report Number
    9613642-2008-00009
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    September 17, 2005
    Report Date
    March 28, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    KWY
    PMA / PMN Number
    K992815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY SURGERY WAS PERFORMED IN 2005, USING MARGRON HIP REPLACEMENT SYSTEM. FIRST REVISION SURGERY WAS PERFORMED FOUR MONTHS LATER, THE STEM WAS FOUND TO BE LOOSE IN THE FEMUR DUE TO INCORRECT SIZE SELECTION BY SURGEON (UNDERSIZED). SECOND REVISION SURGERY WAS PERFORMED EIGHT DAYS LATER, DUE TO IMPLANT ROTATION USING ALTERNATE MFR'S PRODUCT. EXCEPTIONALLY EARLY REVISION APPEARS TO INDICATE SURGEON ERROR. THE EVENT IS BEING REPORTED FOLLOWING A REASSESSMENT BY FACILITY. THE REASSESSMENT WAS CONDUCTED AFTER A TREND REGARDING EARLY REVISION RATES WITH THE MARGRON DEVICE WAS OBSERVED BY THE FOREIGN ORTHOPAEDIC ASSOCIATION IN ITS 2007 FOREIGN NATIONAL JOINT REGISTRY REPORT. THIS OBSERVED TREND AND FACILITY INITIAL ANALYSIS WERE PREVIOUSLY REPORTED TO FDA IN MDR NO. 9613642-2008-00001. AS A PRECAUTIONARY MEASURE, FACILITY HAS TAKEN THE MARGRON DTC SYSTEM OFF THE MARKET IN THE U.S. PENDING FURTHER EVALUATION OF THE DEVICE AND EVENTS, EXCEPT FOR CASES IN WHICH MARGRON-SPECIFIC TOOLS OR COMPONENTS ARE NECESSARY TO PERFORM REVISION OF A MARGRON IMPLANT.

    Description of Event or Problem · 1

    SECOND REVISION OF A REVISED MARGRON HIP IMPLANT WAS PERFORMED DUE TO PT SYMPTOMS OF PAIN. EXCEPTIONALLY EARLY REVISION APPEARS TO INDICATE SURGEON ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM KWY PORTLAND ORTHOPAEDICS LTD. NA 550

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention CERAMIC FEMORAL HEAD 32L| DTC FEMORAL NECK CB