BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCED KNEE SYSTEM

    MDR report key: 3140132 · Received May 29, 2013

    Report

    Report Number
    1722511-2013-00005
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERTER WAS RETURNED FOR EVALUATION, AND INSPECTION OF THE INSERT PRESENTED DAMAGE CONSISTENT WITH FAILURE TO PROPERLY SEAT. IN A DISCUSSION WITH THE SURGEON, HE INDICATED THAT HE MAY HAVE NOT SEATED THE INSERT PROPERLY AT THE TIME OF THE ORIGINAL SURGERY. THE INSERT WAS REPLACED ON (B)(6) 2013, AND WAS SUCCESSFULLY SEATED. NO PREVIOUS ISSUES OF THIS TYPE HAVE BEEN REPORTED. NO FURTHER ACTION IS INDICATED AT THIS TIME, ADD'L INCIDENTS WILL BE INVESTIGATED ACCORDINGLY. ADD'L MODEL #: 163-1707, LOT #: 59808 AND EXPIRATION DATE: 07/2014.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SURGERY WAS PERFORMED TO REPLACE A TIBIAL INSERT IN A PT. IT WAS NOTED THAT THE ORIGINAL TIBIAL INSERT HAD NOT SEATED PROPERLY IN THE TIBIAL TRAY. THE INDEX SURGERY WAS PERFORMED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234832 BALANCED KNEE SYSTEM KNEE REPLACEMENT SYSTEM JWH ORTHO DEVELOPMENT CORP. 162-1700 A106370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R