BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1020523 · Received March 28, 2008

    Report

    Report Number
    9613642-2008-00008
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    October 8, 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

    ASEPTIC LOOSENING OF PRIMARY IMPLANT APPEARS TO BE DUE TO INCORRECT SIZE SELECTION BY SURGEON. ANECDOTAL EVIDENCE SUGGEST SURGEON RESTRAINED IN USE OF WIDER STEMS. INSUFFICIENT INFO TO DRAW FINAL CONCLUSION.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 THE ORTHOPAEDIC ASSOCIATION 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

    REVISION OF PRIMARY MARGRON HIP REPLACEMENT DUE TO REPORTED PT SYMPTOMS OF PAIN AND ASEPTIC LOOSENING OF STEM. LOOSENING APPEARS TO BE DUE TO INCORRECT SIZE SELECTION BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM KWY PORTLAND ORTHOPAEDICS LTD. NA 549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERAMIC FEMORAL HEAD| DTC FEMORAL NECK CA| LIMA ACETABULAR CUP