BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CERAMIC ON CERAMIC HIP

    MDR report key: 1163116 · Received September 16, 2008

    Report

    Report Number
    9616680-2008-00287
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT UNDERWENT CERAMIC ON CERAMIC HIP REPLACEMENT SURGERY IN 2005. IT WAS FURTHER REPORTED THAT, SOMETIME AFTER SURGERY THE PATIENT HEARD AN AUDIBLE SOUND EMANATING FROM HER HIP. AS A RESULT THE PATIENT HAS EXPERIENCED CONSTANT IRRITATION AND DISCOMFORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT CERAMIC ON CERAMIC HIP IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other