BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB LG 9

    MDR report key: 2042104 · Received March 30, 2011

    Report

    Report Number
    9616680-2011-00153
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 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
    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. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 9616680-2011-00154.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WORN INSERT AND PATELLA REQUIRED REVISION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention