BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 5.5

    MDR report key: 1071395 · Received July 3, 2008

    Report

    Report Number
    9616680-2008-00179
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 11, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED "START UP THIGH PAIN NOTICED. PT HAD A RIGHT THR PROCEDURE IN 2006. PT PRESENTED WITH MECHANICAL THIGH PAIN AND GROIN DISCOMFORT. ON X-RAYS PART OF THE FEMORAL COMPONENT APPEARED NOT TO BE SOLIDLY INGROWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE (127 DEG) SIZE 5.5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 14242004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention