BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL OCMPONENTS

    MDR report key: 1973810 · Received January 26, 2011

    Report

    Report Number
    3004594167-2010-00011
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL: CATALOG# T 100025, LOT# T 0904007, TIBIAL EXP. DATE: 05/01/2011. (B)(4) 2009. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALEXANDRIA RESEARCH TECHNOLOGIES CONSIDERS THE INVESTIGATION OF THIS EVENT CLOSED AT THIS TIME. SHOULD THE PRODUCT BE RETURNED OR ADDITIONAL INFORMATION RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE DOCTOR INDICATED THAT A TGS UKA PT (B)(4) WAS SCHEDULED FOR CONVERSION TO A TOTAL KNEE ON WEDNESDAY (B)(6) 2010 FOR PERSISTENT PAIN. HE INDICATED THAT THIS IS DUE TO A LOOSE TIBIAL COMPONENT, AND THAT THERE WAS NO TIBIAL COLLAPSE AND SOME BONE REMODELING. THE ORIGINAL SURGERY DATE WAS (B)(6) 2010. CONVERSION TO A TOTAL KNEE ON (B)(6)2010 WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS UKA FEMORAL AND TIBIAL OCMPONENTS UNICOMPARTMENTAL KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, LLC F 0911002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R