BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA SOLID BACK 46MM

    MDR report key: 1053475 · Received May 28, 2008

    Report

    Report Number
    2249697-2008-00143
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, STILL IMPLANTED IN PT. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE PROCEDURE THE DEFINITIVE SHELL WAS SIGNIFICANTLY PALER IN COLOUR THAN NORMAL. UNFORTUNATELY THE IMPLANT WAS INSERTED BEFORE A PHOTO COULD BE TAKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA SOLID BACK 46MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA HVVMRD

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other