BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE 10 DEG INSERT

    MDR report key: 1044730 · Received May 13, 2008

    Report

    Report Number
    9616680-2008-00121
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K974685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE INVOLVED IN THE REVISION WAS THE C-TAPER HEAD, CATALOG NUMBER 06-3205, LOT UNK. IT CANNOT BE DETERMINED WHETHER ANY DEVICE MFG BY STRYKER CAUSED OR CONTRIBUTED TO THE DISLOCATION. DEVICES ARE NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DISLOCATED 11 YRS AFTER IMPLANT WITH THE PRIMARY DEVICES (UNK) AND WAS SUBSEQUENTLY REVISED IN EARLY 2007. PT DISLOCATED AGAIN AND WAS REVISED A SECOND TIME. NO POST OP X-RAY, OR POST OP REPORTS, OR EXPLANTED IMPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSFIRE 10 DEG INSERT IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention