BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB LG 11

    MDR report key: 2132581 · Received June 10, 2011

    Report

    Report Number
    9616680-2011-00382
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K965173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE PATIENT UNDERWENT A REVISION TKA AND SURGEON RESURFACED THE PATELLA (IT WAS NOT RESURFACED ORIGINALLY) AND REMOVED THE OLD TIBIAL POLY INSERT AND EXCHANGED IT WITH A NEW ONE. THE REASON FOR REMOVAL WAS BASIC WEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION A/P TIB LG 11 IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA XSUKA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention