BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2020505 · Received February 16, 2011

    Report

    Report Number
    9616680-2011-00067
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HIS DESCRIPTION OF THE EVENT IS AS FOLLOWS "I REAMED TO 50MM AS MY NORMAL TECHNIQUE PT'S BONE SOFT DEFINITELY NOT SCLEROTIC. FIFTY SOLID SHELL IMPACTED SEATED EASILY IN ACETABULUM. RIM CLEARED CERAMIC LINER IMPACTED. LINER LOCKED IN ON ONE EDGE ONLY WHEN I TRIED TO REMOVE THE LINER TO REINSERT IT THE SHELL CAME OUT AS WELL. TRIED TO REINSERT SHELL BUT NOW LOOSE IN ACETABULUM RESULT I HAD TO REAM TO 52 AND USE A CLUSTER CUP AND SCREWS TO GET ADEQUATE FIXATION USED A NEW E CERAMIC LINER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other