BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2066033 · Received April 21, 2011

    Report

    Report Number
    3004594167-2011-00004
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 18, 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 NUMBER: T 100015; ADDITIONAL LOT NUMBER: T 0904003; ADDITIONAL EXPIRATION DATE: 11/30/2009. DEVICE MANUFACTURE DATE: 05/01/2009. 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 INFO RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, DOCTOR INDICATED THAT ONE PT, SEEN IN CLINIC ON (B)(6), COMPLAINED OF PERSISTENT PAIN. DOCTOR SAID THE X-RAYS LOOKED FINE; HOWEVER HE HAS SCHEDULED THE PT FOR CONVERSION TO A TOTAL KNEE LATE (B)(6) 2011. ON (B)(4)2011 UPDATE: DOCTOR PROVIDED X-RAYS AND ADDITIONAL INFO VIA E-MAIL ON (B)(4) 2011. INITIAL SURGERY WAS (B)(6) 2009. PT IS (B)(6) FEMALE, (B)(6), PRE-OP ROM 10 TO 105 DEGREES. CONVERSION TO TKA SCHEDULED FOR (B)(6) 2011. CONVERSION TO A TOTAL KNEE ON (B)(6) 2011 WAS UNEVENTFUL. THE ANTERIOR PORTION OF THE TIBIAL PLATEAU HAD COLLAPSED AND THE KNEE WAS CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS UKA FEMORAL AND TIBIAL COMPONENTS UNICOMPARTMENTAL KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, LLC F 0910024

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R