BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 CROSSFIRE INSERT 36 MM ID

    MDR report key: 841254 · Received April 23, 2007

    Report

    Report Number
    2249697-2007-00051
    Event Type
    Injury
    Date Received
    April 23, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 29, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K983502
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TRIDENT PSL SHELL WITH A SECUREFIT MAX 132 DEG STEM IMPLANTED W/ THE 621-00-36F LINER AND 17-3600E CERAMIC HEAD IN 2006. PT FRACTURED FEMUR PERIPROSTHETICALLY, POST OP AND THEN FOUR DAYS LATER WAS REVISED TO 6088 CEMENTED LONG STEM WITH AN 06-3600 C-TAPER HEAD. THE INSERT WAS NOT CHANGED AT THIS TIME. IN 2007, PT DISLOCATED AND ON 02/27/07 THE 06-3600 IMPLANTED THE YEAR BEFORE AND THE 621-00-36G IMPLANTED FOUR DAYS BEFORE THAT SAME YEAR WERE EXPLANTED AND A 690-00-28G CONSTRAINED INSERT AND AN 06-2800 HEAD WERE IMPLANTED. AT THIS TIME, THE SURGEON NOTICED ABRASIVE WEAR ON THE 6 MONTHS OLD CROSSFIRE INSERT THAT WAS EXPLANTED AND WAS CONCERNED THAT IT SHOWED SIGNS OF VISIBLE WEAR AFTER 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 CROSSFIRE INSERT 36 MM ID IMPLANT LWJ STRYKER ORTHOPAEDICS MAHWAH NA 1ZKES

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention