BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB XLG 9

    MDR report key: 2171347 · Received July 18, 2011

    Report

    Report Number
    9616680-2011-00484
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K915512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. D4 - CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT. CAT# 6642-2-200 LOT # 982238 DESCRIPTION: DURA DURATION ALL POLY PAT XLG. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT WAS COMPLAINING OF PAIN WHICH RESULTED IN A LEFT TOTAL KNEE REVISION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention