BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 1583735 · Received January 19, 2010

    Report

    Report Number
    3004594167-2010-00001
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 18, 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

    ADD'L CATALOG # 100026, LOT # 0904008, EXPIRATION DATE: 05/2011. MFR DATE: 05/2009. SURGEON COMMENTS: DURING INITIAL SURGERY, TIBIAL RESECTION WAS RE-CUT TO INCREASE VALGUS TO REPOSITION FEMORAL COMPONENT. THIS RE-CUT MAY HAVE WEAKENED THE TIBIA. SURGEON INDICATES THAT IMPLANT(S) WERE INTACT AND SECURE AND WERE LEFT IN PLACE. NO CORRECTIVE ACTION IS INDICATED. ALEXANDRIA RESEARCH TECHNOLOGIES CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    INITIAL SURGERY WAS IN 2009. PT PRESENTED WITH RIGHT KNEE PAIN IN 2010. X-RAY SHOWED NON-DISPLACED TIBIAL FRACTURE. VERTICAL FRACTURE FROM SAGITTAL CUT DID NOT EXTEND TO CORTEX. SURGERY THE NEXT DAY TO PLACE A FIXATION PLATE ON PROXIMAL TIBIA. UNICOMPARTMENTAL IMPLANTS WERE INTACT AND SECURE AND LEFT IN PLACE. PT WAS HOSPITALIZED OVERNIGHT AND RELEASED THE FOLLOWING DAY.

    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 0910025

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R