BEUDAMED
    FDA Adverse Event Other Summary report: N

    DTC MARGRON HIP REPLACEMENT SYSTEM

    MDR report key: 1023646 · Received April 1, 2008

    Report

    Report Number
    9613642-2008-00027
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    September 15, 2006
    Report Date
    March 31, 2008
    Manufacturer
    PORTLAND ORTHOPAEDICS LTD.
    Product Code
    LPH
    PMA / PMN Number
    K992815
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT KIT REQUESTED FROM CO. FOR APPARENT REMOVAL OF A PRIMARY MARGRON HIP REPLACEMENT DUE TO UNK PT SYMPTOMS. KIT SUPPLIED BY CO., BUT NO INFO FORTHCOMING FROM SURGEON TO CONFIRM DETAILS OF THE EVENT, INCLUDING WHETHER REVISION SURGERY WAS EVEN PERFORMED. DESPITE REPEATED ATTEMPTS BY CO., INCLUDING WRITTEN REQUESTS, NO FURTHER INFO HAS BEEN RECEIVED ON THIS CASE. 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 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

    INSTRUMENT KIT REQUESTED FROM COMPANY FOR APPARENT REMOVAL OF A PRIMARY MARGRON HIP REPLACEMENT DUE TO UNKNOWN PATIENT SYMPTOMS. KIT SUPPLIED BY COMPANY, BUT NO INFORMATION FORTHCOMING FROM SURGEON TO CONFIRM DETAILS OF THE EVENT, INCLUDING WHETHER REVISION SURGERY WAS EVEN PERFORMED. DESPITE REPEATED ATTEMPTS BY COMPANY, NO FURTHER INFORMATION HAS BEEN RECEIVED ON THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTC MARGRON HIP REPLACEMENT SYSTEM FEMORAL STEM LPH PORTLAND ORTHOPAEDICS LTD. NA M624

    Patients

    Seq Age Sex Outcome Treatment
    1 DTC FEMORAL NECK Z| CERAMIC FEMORAL HEAD 28L| LOT # M634