BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022028 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00025
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    November 2, 2006
    Report Date
    March 31, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    LPH
    PMA / PMN Number
    K992815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVISION SURGERY, THE MARGRON HIP REPLACEMENT SYSTEM WAS FOUND TO BE LOOSE IN FEMORAL CANAL, WITH NECK IMPINGING AGAINST ANOTHER MFR'S ACETABULAR CUP LEAVING MULTIPLE SMALL METAL PARTICLES IN THE SURROUNDING SOFT TISSUE. SUCCESSFUL REVISION SURGERY PERFORMED. THE EVENT OCCURRED WITH A NONCOMPLIANT PT WHO AGAINST THE ADVICE OF THE SURGEON MAINTAINED A HIGH LEVEL OF ACTIVITY (GYM WORKOUTS) AFTER THE PRIMARY IMPLANTATION. THE EXCESSIVE ACTIVITY HAS CAUSED THE LOOSENING OF THE STEM. THIS EVENT IS PT RELATED AND HAS NOT BEEN ATTRIBUTED TO THE MARGRON HIP REPLACEMENT. 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 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 SURGERY PERFORMED ON A MARGRON HIP REPLACEMENT DUE TO PT'S SYMPTOMS OF PAIN. THE EVENT OCCURRED WITH A NONCOMPLIANT PT WHO AGAINST THE ADVICE OF THE SURGEON MAINTAINED A HIGH LEVEL OF ACTIVITY AFTER THE PRIMARY IMPLANTATION, WHICH CAUSED THE LOOSENING OF THE STEM. THIS EVENT IS LIKELY PT RELATED AND HAS NOT BEEN ATTRIBUTED TO THE MARGRON HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM LPH PORTLAND ORTHOPAEDICS LTD. NA 373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DTC FEMORAL NECK A| CERAMIC FEMORAL HEAD 32M