BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER FEMORAL STEM +2 HDP CENTRALISERS SMALL CD

    MDR report key: 1873601 · Received October 12, 2010

    Report

    Report Number
    9616680-2010-00631
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "BROKEN EXETER STEM REMOVAL/LINER EXCHANGE WITH EXISTING SHELL. SUBSEQUENT RESTORATION MODULAR IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER FEMORAL STEM +2 HDP CENTRALISERS SMALL CD IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA GV272474

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention