BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX DOVETAIL TIBIAL TRAY

    MDR report key: 1171976 · Received September 18, 2008

    Report

    Report Number
    1226188-2008-00029
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    OMNI LIFE SCIENCE INC
    Product Code
    HSH
    PMA / PMN Number
    K060192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TKA, TIBIAL LOCKING BOLT WOULD NOT ENGAGE IN TIBIAL TRAY. SURGEON WAS ABLE TO ENLARGE HOLE TO ACCEPT TIBIAL LOCKING BOLT. THERE WAS A 90 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX DOVETAIL TIBIAL TRAY CEMENTED TIBIAL COMPONENT HSH OMNI LIFE SCIENCE INC SZ 4 RIGHT 2991

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention