BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 48MM

    MDR report key: 1163120 · Received September 16, 2008

    Report

    Report Number
    9616680-2008-00283
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUP WAS IN EXTREME VERTICAL POSITION. COMPONENTS AND REMOVED WITH LITTLE DIFFICULTY. CUP REMOVED FROM ACETABULUM WITH LITTLE DIFFICULTY. SURGEON SUGGESTED THAT ONE POSSIBLE REASON FOR THE REVISION WAS THAT THE PATIENT WAS PART OF A CONGENITAL CASE. THE SHALLOW ACETABULUM PREVENTED OR MADE IT DIFFICULT TO ACHIEVE APPROPRIATE COVERAGE FOR THE CUP. THERE WERE NO SCREWS USED IN THE PRIMARY CASE AND THAT MAY HAVE CONTRIBUTED TO THE CUP SLIDING INTO AN OVERLY VERTICAL POSITION. SURGEON NOTICED SYNOVATIC REACTION WITHIN THE JOINT CAPSULE, SUGGESTED THE POSSIBILITY OF PARTICLE DEBRIS. BEARING SURFACES WERE CLOSELY INSPECTED AND NO SCORING OR SCRATCHING WAS OBSERVED. HOWEVER, UPON CLOSE INSPECTION OF CERAMIC INSERT, SCRATCHING WAS NOTICED ON TI RIM. SURGEON SUGGESTED POSSIBILITY OF FEMORAL NECK TO RIM IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL SOLID BK 48MM IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 6547301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention