BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIDENT HEMISPHERICAL SOLID BACK SHELL

    MDR report key: 1032468 · Received April 16, 2008

    Report

    Report Number
    9616680-2008-00093
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT COMPLAINED OF PAIN AND SWELLING. SURGEON DESCRIBES A SOFT MASS IN GENERAL HIP AREA." REVISION SURGERY IS NOT PLANNED AND THE DEVICE IS NOT AVAIL FOR EVAL. THERE IS NO INFO AVAIL TO INDICATE THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BACK SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 11161501

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other