BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSENSUS PS KNEE SYSTEM

    MDR report key: 4232331 · Received July 30, 2014

    Report

    Report Number
    2952369-2014-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    July 28, 2014
    Manufacturer
    CONSENSUS ORTHOPEDICS INC.
    Product Code
    JWH
    PMA / PMN Number
    K954818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR'S PULLED AND REVIEWED, COMPLAINT RECORDS REVIEWED NO SIMILAR ISSUES IDENTIFIED. CLINICAL AND ENGINEERING REVIEW OF PATIENT X-RAYS CONDUCTED. ENGINEERING EVALUATION PERFORMED ON EXPLANTS. PART/CATALOG #: 2242-0-5610, PRODUCT DESCRIPTION: SIZE 5/6, 10MM, CONGRUENT TIBIAL INSERT, LOT #: 610216-18; 2252-1-0005, SIZE 5 PS FEMUR, 233263-01; 2582-0-0005, SIZE 5 TIBIAL BASEPLATE, 475853-16.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED 2 DISLOCATED PS INSERTS. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2012. THE FIRST DISLOCATION OCCURRED IN (B)(6) OF 2013 WITH A POLY SWAP FOR A NEW INSERT ON (B)(6) 2013. THE SECOND DISLOCATION OCCURRED IN (B)(6) OF 2014 WITH REVISION SURGERY TO A STRYKER TRIATHLON TS KNEE SYSTEM ON (B)(6) 2014. THE PATIENT DOES NOT REMEMBER THE CAUSE OF THE FIRST OCCURRENCE. THE SECOND OCCURRENCE HAPPENED WHEN THE PATIENT WAS GETTING UP FROM THE COUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444302 CONSENSUS PS KNEE SYSTEM TOTAL KNEE SYSTEM JWH CONSENSUS ORTHOPEDICS INC. 2242-0-5610 610216-08

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention