BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB MED 9

    MDR report key: 1071396 · Received July 3, 2008

    Report

    Report Number
    9616680-2008-00183
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    May 28, 2007
    Report Date
    June 17, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HSH
    PMA / PMN Number
    K936292
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT LINER FROM PRIMARY KNEE REPLACEMENT REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION A/P TIB MED 9 IMPLANT HSH STRYKER ORTHOPAEDICS CORK NA 18742001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention