BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICOMPARTMENTAL KNEE COMPONENT

    MDR report key: 2657248 · Received July 10, 2012

    Report

    Report Number
    3004594167-2012-00007
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    June 15, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEMORAL: LOT 1103006-A, CATALOG # 100280. MFG. DATE: JUNE 2011, EXP. DATE: JUNE 2013. TIBIAL BASEPLATE: LOT 1009038-A, CATALOG # 100297, MFG. DATE: FEBRUARY 2011, EXP. DATE: FEBRUARY 2013. TIBIAL INSERT: LOT 1009021-A, CATALOG # 100325, MFG. DATE: FEBRUARY 2011, EXP. DATE: FEBRUARY 2013. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. (B)(6) 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

    PATIENT PRESENTED WITH TIBIAL COLLAPSE. CONVERTED TO TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICOMPARTMENTAL KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 1103006-A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R