BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRG KNEE P/S BEARING INSERT S

    MDR report key: 1060540 · Received June 12, 2008

    Report

    Report Number
    9616680-2008-00153
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGERY, THE TIBIAL BEARING INSERT DID NOT LOCK WITH THE TIBIAL BASE PLATE (#7) BECAUSE THE LOCKING WIRE CAME OFF FROM THE INSERT. SPARE PRODUCT WAS USED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NRG KNEE P/S BEARING INSERT S IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 24644401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other