BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 54MM

    MDR report key: 2091368 · Received May 5, 2011

    Report

    Report Number
    2249697-2011-00664
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DR WAS USING THE TRIDENT HEMISPHERICAL ACETABULAR SYSTEM. HE REAMED TO 53MM AND ASKED TO TRIAL A 54MM TRIDENT WINDOW TRIAL USING IMPACTOR HANDLE (B)(4). HE SCREWED THE WINDOW TRIAL ONTO THE IMPACTOR HANDLE (B)(4) AND IMPACTED THE TRIAL AND AFTER IMPACTING THE TRIAL, THE HANDLE CAME AWAY AND DR NOTICED A SMALL THREAD OF METAL CAME AWAY FROM THE TRIAL. HE COULD NOT SCREW THE IMPACTOR HANDLE (B)(4) BACK ONTO THE TRIAL. HE HAD TO USE AN OSTEOTOME AND A BONE HOOK TO REMOVE THE WINDOW TRIAL FROM THE PATIENT'S ACETABULUM. THE SURGEON REMOVED THE WINDOW TRIAL FROM THE PATIENT USING AN OSTEOTOME AND A BONE HOOK. IT TOOK ABOUT 60-90 SECONDS TO RETRIEVE THE WINDOW TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 54MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention