BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG)

    MDR report key: 1141007 · Received August 27, 2008

    Report

    Report Number
    9616680-2008-00253
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW.

    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 5.88 Y. THE PATIENT PRESENTED A UCLA SCORE OF 6 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 ACCOLADE (127 DEG) IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 3288104

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention