BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA KNEE SYSTEM

    MDR report key: 3299612 · Received August 14, 2013

    Report

    Report Number
    3004594167-2013-00006
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 17, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED WITH INFORMATION THAT IS AVAILABLE TO COMPLY WITH THE 30 DAY REPORTING REQUIREMENT. ON THREE OCCASIONS ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM THE REVISION SURGERY AND TO GATHER ADDITIONAL DATA, HOWEVER A RESPONSE IS YET TO BE PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND A FOLLOW UP REPORT WILL BE SUBMITTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO ISSUES AND PRODUCT WAS MANUFACTURED TO SPEC. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PMA/510(K): 510(K) # K090024 COVERS INITIAL RELEASE OF TGS USA SYSTEM INCLUDING ALL INSTRUMENTATION AND FEMORAL COMPONENT, 510 (K) # K101206 COVERS THE TIBIAL BASEPLATE COMPONENT AND TIBIAL INSERT COMPONENT. TIBIAL BASEPLATE: LOT: 1009041-A, CATALOG #: 100300, MFG. DATE: 02/2011, EXP. DATE: 02/2013. TIBIAL INSERT: LOT: 1009030-A, CATALOG #: 100337, MFG. DATE: 02/2011, EXP. DATE: 02/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT A PATIENT WITH THE INITIALS RG WAS SCHEDULED FOR REVISION SURGERY TO REPLACE A TGS UKA KNEE IMPLANT AND THAT THE REVISION WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389104 TGS UKA KNEE SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HSX ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 1111002-A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R