BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 1918350 · Received December 8, 2010

    Report

    Report Number
    3004594167-2010-00009
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 28, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: LOT# 0910036, CATALOG# 100036, EXP DATE: 10/2011, DEVICE MANUFACTURE DATE: 10/2009. 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

    THE DOCTOR INDICATED THAT ONE OF HIS PTS, WHO RECEIVED A TGS UKA ON (B)(6) 2010, WAS SEEN IN CLINIC APPROXIMATELY (B)(6) 2010 AND REPORTED WITH PAIN, NO ADVERSE X-RAY FINDINGS. THE DOCTOR SCHEDULED A FOLLOW UP EXAM FOR (B)(6) 2010; PT PRESENTED WITH A TIBIAL COMPONENT COLLAPSE THAT DAY. PT WAS SCHEDULED FOR CONVERSION TO A TOTAL KNEE ON (B)(6) 2010. DURING THE PROCEDURE, THE DOCTOR NOTED THAT THE PROXIMAL TIBIA WAS FRACTURED. THE SURGEON NOTED THAT THE TP WAS HUNTING AND FELL SEVEN WEEKS AGO AND THE PAIN BEGAN IMMEDIATELY AFTER THIS AND PROGRESSED. X-RAYS SHORTLY AFTER THE FALL WERE UNREMARKABLE. DURING THE SURGERY ON (B)(6) 2010, IT WAS CLEAR HE SUSTAINED A FRACTURE OF THE ANTEROMEDIAL TIBIAL RIM.

    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 0911004

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R