BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2090879 · Received May 12, 2011

    Report

    Report Number
    9616680-2011-00295
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THE ALLEGEDLY, "THE PATIENT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM." IT WAS FURTHER ALLEGED THAT, "THE PATIENT IS EXPERIENCING " VIBRATION IN HIS HIP WHILE WALKING, POPPING AND SQUEAKING AND PAIN IN THE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA U8343704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other