BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 48MM

    MDR report key: 1509086 · Received September 24, 2009

    Report

    Report Number
    9616680-2009-00409
    Event Type
    Malfunction
    Date Received
    September 24, 2009
    Date of Event
    September 4, 2009
    Report Date
    September 4, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K001448
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IT WAS REPORTED THAT, THE PT ALLEGES FAILURE OF HER HIP PROSTHESIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BK 48MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 10379301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other