BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 54MM

    MDR report key: 1082421 · Received July 21, 2008

    Report

    Report Number
    9616680-2008-00213
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 26, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REAMED THE ACETABULUM, STARTING AT A 48 REAMER AND WORKED HIS WAY TO A 53, WHEN HE DECIDED TO STOP. HE ASKED FOR A 54MM HEMISPHERICAL CUP. WHEN HE PUT THE IMPLANT INTO THE PT, HE FELT THAT THE IMPLANT WAS LOOSE. HE REAMED WITH A 54 REAMER, AND SEATED THE 56 CUP WITHOUT FURTHER INCIDENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 26933801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other