BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1022316 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00019
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    June 6, 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

    PRIMARY MARGRON HIP REPLACEMENT DONE IN 2003. VERY ACTIVE PT PRE AND POST OPERATIVELY; THIGH PAIN WAS REPORTED AS BEING WORSE DURING HIGH LEVELS OF ACTIVITY, EXERCISING. PT REMAINED VERY ACTIVE, EVEN AGAINST ADVICE OF HIS SURGEON, POST OPERATIVELY. X-RAYS INDICATES PROSTHESIS INSERTED IN VARUS (NOT INSERTED PERFECTLY), LEADING TO CURRENT THIGH PAIN CAUSED BY TIP IMPINGMENT OF THE STEM. NOT DEVICE RELATED; STEM INSERTED INCORRECTLY DURING PRIMARY PROCEDURE DUE TO SURGEON ERROR, WITH THE RESULTING PAIN BEING ACCENTUATED BY THE RAISED LEVELS OF ACTIVITY BY THE PATIENT. 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 INTERNATIONAL ORTHOPAEDIC ASSOCIATION IN ITS 2007 REGISTRY REPORT. THIS OBSERVED TREND AND PORTLAND'S INITIAL ANALYSES 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 PRIMARY MARGRON HIP REPLACEMENT DUE TO PATIENT SYMPTOMS OF THIGH PAIN. NEED FOR REVISION APPARENTLY DUE TO SURGEON ERROR, AND POSSIBLY THE HIGH ACTIVITY LEVEL OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM KWY PORTLAND ORTHOPAEDICS LTD. NA M494

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# M475| DTC FEMORAL NECK B+4