BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022027 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00026
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    November 7, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY SURGERY WAS PERFORMED IN 2006. PT PRESENTED WITH THIGH PAIN 2 MOS POST PRIMARY SURGERY; STEM FOUND TO BE LOOSE IN FEMUR. REVISION OF PRIMARY IMPLANT CARRIED OUT ON APPROX TWO MONTHS AND A WEEK LATER. PORTLAND ORTHOPAEDICS WAS NOTIFIED THROUGH AN INCOMPLETE INCIDENT REPORT; ADDITIONAL INFO REQUESTED, AND RECEIVED THE FOLLOWING MONTH. OTHER DATA (E.G., X-RAYS, EXPLANTED DEVICE) NOT FORTHCOMING TO MAKE CONCLUSIVE JUDGMENT AS TO THE CAUSE OF THE STEM LOOSENING. GIVEN THE VERY EARLY REVISION PERIOD, IT IS LIKELY DUE TO INCORRECT SIZE SELECTION DURING PRIMARY SURGERY. PT SUCCESSFULLY REVISED WITH A LARGER STEM. 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 SYMPTOMS OF THIGH PAIN CAUSED BY A PREMATURE LOOSENING OF THE FEMORAL STEM. CAUSE OF LOOSENING IS NOT CLEAR, BUT IT IS BELIEVED THAT INCORRECT DEVICE SIZE SELECTION DURING THE PRIMARY SURGERY IS THE POSSIBLE OR PROBABLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM LPH PORTLAND ORTHOPAEDICS LTD. NA 742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERAMIC FEMORAL HEAD 32S| DTC FEMORAL NECK CA