BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MMI TITANIUM IMPLANT

    MDR report key: 2264972 · Received September 20, 2011

    Report

    Report Number
    3004082045-2011-00026
    Event Type
    Injury
    Date Received
    September 20, 2011
    Date of Event
    March 24, 2010
    Report Date
    August 22, 2011
    Manufacturer
    MEMOMETAL TECHNOLOGIES SA
    Product Code
    HTY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. AT THIS TIME, IT IS UNK WHETHER THE DEVICE WILL BE AVAILABLE FOR INVESTIGATION DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    THE PT ALLEGES THAT THE MMI TITANIUM IMPLANT IN HER LEFT BIG TOE WAS DEFECTIVE AND FRACTURED. IT LOOKS LIKE SHE INITIALLY FRACTURED HER TOE IN (B)(6) 2008, HAD SURGERY IN (B)(6) 2009 AND A SUBSEQUENT SURGERY IN (B)(6) 2010 WHEREIN SHE HAD THE MMI IMPLANT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MMI TITANIUM IMPLANT IMPLANT HTY MEMOMETAL TECHNOLOGIES SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R