BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022025 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00029
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    November 30, 2006
    Report Date
    March 31, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    KWY
    PMA / PMN Number
    K992815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT SYMPTOMS OF ACHE ALMOST IMMEDIATELY FOLLOWING PRIMARY SURGERY OF LATE 2004. REVISION SURGERY PERFORMED IN 2006 DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. THE LOOSENING WAS LIKELY DUE TO USE OF AN UNDERSIZED COMPONENT IN THE PRIMARY PROCEDURE. PAIN SETTLED FOLLOWING REVISION TO A LARGER (WIDER) STEM SIZE. THE EVENT IS BEING REPORTED FOLLOWING A REASSESSMENT BY PORTLAND ORTHOPAEDICS. THE REASSESSMENT WAS CONDUCTED AFTER A TREND REGARDING EARLY REVISION RATES WITH THE MARGRON DEVICE WAS OBSERVED BY ANOTHER COUNTRY ORTHOPAEDIC ASSOCIATED IN ITS 2007 NATIONAL JOINT REGISTRY REPORT. THIS OBSERVED TREND AND PORTLAND'S INITIAL ANALYSIS WERE PREVIOUSLY REPORTED TO FDA IN MDR NO 9613642-2008-00001. AS A PRECAUTIONARY MEASURE, PORTLAND 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

    PT PRESENTED WITH AN ACHE ALMOST IMMEDIATELY POSTOPERATIVELY FOLLOWING PRIMARY IMPLANTATION OF A MARGRON HIP REPLACEMENT. THE IMPLANT WAS SUBSEQUENTLY REVISED. DURING REVISION OF THE PRIMARY IMPLANT, ASEPTIC LOOSENING OF THE STEM WAS NOTED. IT IS LIKELY THAT THE LOOSENING WAS DUE TO UNDERSIZING OF THE STEM COMPONENT. REVISION TO LARGER STEM SIZE RESULTED IN A SETTLING OF THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM KWY PORTLAND ORTHOPAEDICS LTD. NA 526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERAMIC FEMORAL HEAD 32L| DTC FEMORAL NECK BA - LOT# 717