BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022033 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00021
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    September 5, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY SURGERY WAS DONE USING A NON-PORTLAND NAIL. THE PT LATER HAD REVISION SURGERY USING A MARGRON-DTC HIP REPLACEMENT SYSTEM. A SECOND REVISION (THE CURRENT EVENT) WAS DONE LATER DUE TO ASEPTIC LOOSENING OF THE MARGRON STEM. THE PT WAS FOUND TO BE SHORT ON AFFECTED SIDE AND THE STEM WAS REVISED WITH AN ALTERNATE MFR'S HIP REPLACEMENT SYSTEM. NO CONCLUSIVE EVIDENCE IS AVAILABLE, BUT IT APPEARS THAT THE FEMORAL STEM MAY HAVE BEEN INCORRECTLY SIZED FOR LENGTH (TOO SHORT), WHICH MAY HAVE CONTRIBUTED TO THE LOOSENING. 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'S 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 SYMPTOMS OF THIGH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM LPH PORTLAND ORTHOPAEDICS LTD. NA 655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DTC FEMORAL NECK AZ| DTC MODULAR EXTENSION ZZ6| COCR FEMORAL HEAD 32XL