BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG KNEE P/S NRG BEARING INSERT S

    MDR report key: 1760452 · Received July 13, 2010

    Report

    Report Number
    9616680-2010-00462
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    July 1, 2009
    Report Date
    June 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFORMATION HAS BEEN PROVIDED. NO OTHER SPECIFIC INFORMATION IS AVAILABLE FROM THE RESEARCH CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE TIBIAL INSERT COMPONENT WAS REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 2.29Y. THE PATIENT PRESENTED WITH A (B)(4) SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 4."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NRG KNEE P/S NRG BEARING INSERT S IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 21850601

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention