BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 54MM

    MDR report key: 1160470 · Received September 12, 2008

    Report

    Report Number
    9616680-2008-00280
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COMPLAINED OF PAIN. WENT BACK TO DR AND GENERAL SURGEON, NOT SURE IF SPINE OR HERNIA. FINALLY CAME BACK TO SURGEON TO CHECK AND FOUND CUP TO BE LOOSE. CUP CAME OUT VERY EASILY WITH LITTLE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BK 54MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 12410701

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention