BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE 10 DEG INSERT

    MDR report key: 1030114 · Received April 14, 2008

    Report

    Report Number
    9616680-2008-00086
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    January 8, 2008
    Report Date
    March 17, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DR WAS SCHEDULED TO REVISE PT'S HIP REPLACEMENT IN 2008. THE REVISION ENTAILS THE REMOVAL OF THE ACETABULAR COMPONENT, WHICH APPEARED TO BE IN TOO VERTICALLY AS WELL AS THE ENCLOSED LINER, AND THE FEMORAL HEAD. THE DR FOUND THE LINER TO BE BROKEN AT THE SUPERIOR/POSTERIOR ASPECT OF THE RIM OF THE LINER. THE LINER WAS REMOVED, THE LOCKING RING WAS REMOVED AND DISCARDED, THE ACETABULAR COMPONENT WAS REMOVED, AND THE FEMORAL HEAD WAS ALSO REPLACED, BUT LEFT THE WELL FIXED STEM IN PLACE. THE SURGERY WAS COMPLETED AS PLANNED WITH A REVISED SHELL, LINER, FOUR BONE SCREWS AND A DOME HOLE PLUG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSFIRE 10 DEG INSERT IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 74030701

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention