BEUDAMED
    FDA Adverse Event Other Summary report: N

    NRG KNEE CR NRG BEARING INSERT S

    MDR report key: 1633292 · Received March 10, 2010

    Report

    Report Number
    9616680-2010-00232
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 24, 2010
    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 MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, OUR QUALITY DEPARTMENT RECEIVED THE FOLLOW-UP REPORT INFO ABOUT AN EVENT WHICH RE-OCCURRED DURING THE PT STUDY (B)(6) 2007 WITH THE PRODUCT (B)(4). SURGEON OF THE ORTHOPEDIC SURGERY DEPARTMENT OF THE HOSPITAL, REPORTED VIA (B)(4), THAT A (B)(6) MALE PT WITH A TOTAL KNEE ENDOPROSTHESIS IMPLANT UNDERWENT A REVISION SURGERY ON (B)(6) 2010, DUE TO A RE-OCCURRED RUPTURE OF THE QUADRICEPS-TENDON OF THE LEFT LEG WHICH WAS STATED ON (B)(6) 2010 AFTER THE SURGICAL IMPLANT RECONSTRUCTION CARRIED OUT ON (B)(6) 2009. ACCORDING TO HIS INFO, THE PT SHOULD HAVE MENTIONED BEFORE BEING NOT ABLE TO EXTEND HIS LEG ON (B)(6) 2010. SURGEON REPORTED THAT THE PT IS STILL RECOVERING, SO THAT THIS PROCESS HAS NOT YET BEEN RESOLVED. IT IS WRITTEN IN THE STUDY DOCUMENT THAT THIS RE-OCCURRED EVENT WAS CLASSIFIED AS SEVERE ADVERSE EVENT WHICH IS NOT NECESSARILY RELATED TO THE PRODUCT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention