BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON CRUC NON BED B/P M2

    MDR report key: 2971319 · Received May 13, 2008

    Report

    Report Number
    9610726-2008-00118
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K926228
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED "PROGRESSIVE PAIN IN LEFT KNEE WITH IMPLANT SUBSIDENCE FROM 18 MONTHS POST PRIMARY SURGERY." PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON CRUC NON BED B/P M2 IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK L4HPE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention