BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG KNEE CR NRG BEARING INSERT S

    MDR report key: 2001679 · Received February 22, 2011

    Report

    Report Number
    9616680-2011-00078
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    October 25, 2010
    Report Date
    February 7, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K042343
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SENIOR CLINICAL RESEARCH ASSOCIATE, RECEIVED AN ADVERSE EVENT REPORT FROM THE SURGEON. IT STATES THAT AFTER RE-RUPTURE OF QUADRICEPS-TENDON AND TENDON RECONSTRUCTION TWO FURTHER SURGERIES BECAME NECESSARY. THE PT SHOWED ON AMBULANT CHECK-UP SIGNS OF INFECTION. TAKEN HYGIENIC FROM JOINT SHOWED COAGULASE NEGATIVE BUT (B)(6). AN EXPLANTATION TOOK PLACE IN (B)(6) 2010 AND AMBIOTIC AND A SPACER WERE IMPLANTED. AFTER STERILE INTRA-ARTICULAR CONDITION A RE-IMPLANTATION OF A SCORPIO NRG-PS TOOK PLACE IN (B)(6) 2010. ON THE SAE, THE SURGEON STATES THAT THERE IS NO RELATIONSHIP TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NRG KNEE CR NRG BEARING INSERT S IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 30525001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention