BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 CROSSFIRE INSERT 32MM ID

    MDR report key: 1702507 · Received May 26, 2010

    Report

    Report Number
    9616680-2010-00360
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    May 17, 2006
    Report Date
    May 17, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983502
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 540-11-54F, LOT # 2518601, DESCRIPTION: TRIDENT PSL HA SOLID BACK 54MM. CAT # 6098-0735, LOT # 68623502, DESCRIPTION: OMNIFIT EON CS 132 NK SIZE 7 STEM 35 MM 132 NECK. CAT # 06-3205, LOT # 68153501, DESCRIPTION: C-TAPER COCR LFIT HEAD 32MM/+5. CAT # 6191-1-001, LOT # RCI152, DESCRIPTION: SIMPLEX P FULL DOSE 1 PACK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. MORE SPECIFIC INFORMATION IS NOT AVAILABLE FROM THE RESEARCH CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 5.3 Y. UCLA ACTIVITY SCORES WERE NOT AVAILABLE FOR THIS PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 CROSSFIRE INSERT 32MM ID IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 02253401

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention