BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM

    MDR report key: 1150466 · Received September 5, 2008

    Report

    Report Number
    2249697-2008-00254
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB CONSTRAINTS AT OUR INSTITUTION. RETAINED AT DREXEL IMPLANT RESEARCH CENTER. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE ARTHROPLASTY WAS REVISED DUE TO FEMORAL LOOSENING. THE ACETABULAR LINER AND FEMORAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 7.44 Y. THE PT PRESENTED A UCLA SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM UCLA SCORE OF 7 SINCE IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL STEM IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention