BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT CERAMIC ON CERAMIC

    MDR report key: 1812926 · Received August 16, 2010

    Report

    Report Number
    9616680-2010-00518
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER LEGAL AFFAIRS HAD BEEN CONTACTED FOR INFO. DUE TO THE ONGOING LITIGATION, ADDITIONAL INFO IS NOT YET AVAILABLE. IF ADDITIONAL INFO IS RECEIVED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PT IS EXPERIENCING "SQUEAKING" FROM THE SYSTEM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other