BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1020507 · Received March 28, 2008

    Report

    Report Number
    9613642-2008-00017
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    April 10, 2006
    Report Date
    March 28, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    KWY
    PMA / PMN Number
    K032641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVISION SURGERY, IT WAS CONFIRMED THAT THE NECK WAS AT AN INCORRECT ANGLE (RETROVERTED AFTER IMPACTION 30 DEGREES) WHICH CAUSED IT TO HIT THE ACETABULAR CUP (CAUSING 'CLICKING' NOISES). CORRECTIVE ACTION INCLUDED THE USE OF AN IDENTICAL REPLACEMENT NECK BEING FITTED WITH BETTER ANTEVERTED POSITIONING AND LONGER (+4) BALL. EXPLANTED NECK WAS REVIEWED, WITH ITS TAPER GEOMETRY CHECKED USING AN AZ TAPER GAUGE AND WAS FOUND TO BE WITHIN SPEC. DEVICE MFG HISTORY FILES WERE ALSO REVIEWED WITH NO IRREGULARITIES BEING NOTED. AVAILABLE INFO SUGGESTS SUB-OPTIMAL NECK POSITIONING BY SURGEON OR THE FAILURE OF THE PT TO FOLLOW POST-OPERATIVE INSTRUCTION RESULTED IN NEED FOR REVISION SURGERY. THE EVENT IS BEING REPORTED FOLLOWING A REASSESSMENT BY PORTLAND ORTHOPAEDICS. THE REASSESSMENT WAS CONDUCTED AFTER A TREND REGARDING EARLY REVISION RATES WITH THE MARGON 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 SURGERY PERFORMED ON PRIMARY MARGRON HIP REPLACEMENT DUE TO PT SYMPTOMS OF 'CLICKING' NOISES HIP DISCOMFORT (PAIN). AVAILABLE INFO SUGGESTS THAT SUB-OPTIMAL NECK POSITIONING BY SURGEON OR THE FAILURE OF THE PT TO FOLLOW POST-OPERATIVE INSTRUCTIONS NECESSITATED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL NECK KWY PORTLAND ORTHOPAEDICS LTD. NA 807

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention CERAMIC FEMORAL HEAD 32M| DTC FEMORAL STEM Z+2