BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 1060539 · Received June 12, 2008

    Report

    Report Number
    9616680-2008-00151
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 16, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE CUP WAS INSERTED DURING A PRIMARY HIP, SURGEON TRIED AND FAILED TO INSERT 3 SCREWS THROUGH CLUSTER SCREW HOLES IN CUP. THE SURGEON STATED THAT HE FELT THERE WAS A PROBLEM WITH ONE OF THE SCREW HOLES (BOTTOM FAR RIGHT). THE CUP WAS REMOVED FROM THE PATIENT AND THE SURGEON PROCEEDED TO INSERT A 60MM HEMISPHERICAL CUP. AFTER TRYING AND FAILING TO INSERT MORE SCREWS INTO THE NEW CUP, THE SURGEON WAS SATISFIED WITH THE CUPS FIXATION AND INSERTED A LINER. LATER IN THE PROCEDURE, THE SURGEON WAS PERPLEXED BY HIS INABILITY TO GET ANY SCREWS INTO THE CUP, AND PROCEEDED TO ASK THE ANESTHESIOLOGIST ABOUT PREVIOUS CANCER RADIATION TREATMENTS. IT WAS REVEALED THAT THE PATIENT HAD PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 26357801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other