BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 1918373 · Received December 8, 2010

    Report

    Report Number
    3004594167-2010-00010
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 24, 2010
    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 INFO: LOT# T 0904008, CATALOG# T 100026, EXP DATE: 05/2011. DEVICE MANUFACTURE DATE: 05/2009. PRODUCT WAS NOT RETURNED FOR EVAL. 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

    DOCTOR FORWARDED FOLLOW-UP X-RAYS VIA E-MAIL ON (B)(6), 2010 WITH A NOTE INDICATING PT IS FEMALE WHO HAD BILATERAL TGS UKA PROCEDURES. "APPEARS TO HAVE SUBSIDED ANTERIOR BUT QUESTION OF VERTICAL CRACK ON INITIAL 4 WEEK FILM." THE ORIGINAL SURGERY DATE WAS (B)(6), 2010. FIRST FOLLOW UP IN (B)(6), 2010 AND SECOND FOLLOW UP ON (B)(6), 2010. CONVERTED TO TOTAL KNEE ON (B)(6), 2010.

    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 0911002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R