BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL MULTI

    MDR report key: 1881574 · Received October 20, 2010

    Report

    Report Number
    9616680-2010-00658
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT CALLED COORDINATOR FOR NEOS STATING THAT SHE IS HAVING PROBLEM WITH HER HIP REPLACEMENT AND THAT SHE WAS AWARE OF IT BEING RECALLED ALTHOUGH SHE WAS NEVER NOTIFIED OF THE RECALL. PATIENT ALSO STATED THAT SHE WOULD BE GOING TO ANOTHER SURGEON IN (B)(6) FOR A SECOND OPINION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL MULTI IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 17728201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other