BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYCAD UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 7919999 · Received September 28, 2018

    Report

    Report Number
    3012086398-2018-00001
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    July 18, 2018
    Report Date
    July 25, 2018
    Manufacturer
    BODYCAD LABORATORIES, INC.
    Product Code
    HSX
    PMA / PMN Number
    K163700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REASON FOR FEMORAL AND TIBIAL COMPONENT LOOSENING IS UNKNOWN.

    Description of Event or Problem · 1

    SURGICAL INTERVENTION, I.E. REVISION KNEE SURGERY, FOR LOOSENING OF UNICOMPARTMENTAL FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759278 BODYCAD UNICOMPARTMENTAL KNEE SYSTEM UNICOMPARTMENTAL KNEE HSX BODYCAD LABORATORIES, INC. 010003

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention