BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 3060269 · Received April 11, 2013

    Report

    Report Number
    1822565-2013-00630
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TYPE OF DAMAGE AND WEAR OBSERVED ON THIS DEVICE AND SUBSEQUENT DISSOCIATION CAN OCCUR IF THE DEVICE IS NOT COMPLETELY SNAPPED INTO POSITION DURING IMPLANTATION. ANOTHER POSSIBILITY IS THAT THE DEVICE DISLODGED AFTER IMPLANTATION DUE TO MISALIGNMENT OF COMPONENTS OR PT FACTORS, SUCH AS WEIGHT, BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), OR POSSIBLE TRAUMA. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE MEASURED DIMENSIONS WERE WITHIN SPECIFICATION AS RETURNED. THE SNAPLOCK HAD FRACTURED OFF AND THE POSTERIOR REGION OF THE BACKSIDE WAS HEAVILY WORN AS RETURNED. MFG DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE ARTICULAR SURFACE DISENGAGING FROM THE TIBIAL TRAY. DURING REVISION SURGERY; A BROKEN PIECE OF POLY WAS FOUND IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156369 NATURAL KNEE FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER, INC. 60874728

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention