BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 1901141 · Received November 10, 2010

    Report

    Report Number
    9616680-2010-00722
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    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 EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "HAVING DIFFICULTY SEATING TRIDENT INSERT COMPLETELY INTO TRIDENT SHELL. TRIED 5 TIMES TO SEAT PROPERLY TO NO AVAIL SO USED IDENTICAL INSERT WITH DIFFERENT LOT NUMBER AND SEATED PROPERLY FIRST TIME ON IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA 34146304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other