BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 1883473 · Received October 21, 2010

    Report

    Report Number
    1226188-2010-00014
    Event Type
    Other
    Date Received
    October 21, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRIALING OF SIZE 4 TIBIAL BASEPLATE MADE BY SURGEON. BASEPLATE DID NOT SIT APPROPRIATELY ON THE PREPARED BONE AFTER PUNCH WAS MADE RESULTING IN MALROTATION. REMOVING THE SIZE 4 BASEPLATE AND CEMENT AND SWITCHING TO THE SIZE 5 RESULTED IN AN APPROXIMATE DELAY OF 30 MINUTES. SURGEON SUCCESSFULLY IMPLANTED SIZE 5 BASEPLATE. PT IS DOING FINE.

    Description of Event or Problem · 1

    KNEE SURGERY PERFORMED ON (B)(6) 2010. SIZE 4 TIBIA BASEPLATE WAS TRIALED AND DETERMINED TO BE THE CORRECT SIZE. THE SIZE 4 KEEL PUNCH WAS USED FOR FINAL PREPARATION OF THE BONE. SURGEON WAS SATISFIED WITH THE ROTATION OF THE TIBIA BASEPLATE TRIAL WHEN THE KEEL PUNCH WAS USED. WHEN THE SURGEON WENT TO PLACE THE FINAL IMPLANT WITH CEMENT, THE BASEPLATE APPEARED TO BE MALROTATED. THE SURGEON WAS NOT ABLE TO DETERMINE ANY CAUSE FOR THIS ISSUE AND WAS DISSATISFIED WITH THE IMPLANT'S POSITION SO HE REMOVED THE TIBIA BASEPLATE AND CEMENT. THE SURGEON THEN USED THE KEEL PUNCH FOR A SIZE 5 TIBIA BASEPLATE AND WAS ABLE TO PLACE THE SIZE 5 TIBIA BASEPLATE IMPLANT WITH NO ISSUES. HE WAS SATISFIED WITH THE FINAL PLACEMENT OF BASEPLATE, INCLUDING ROTATION. PT IS DOING WELL AS OF THE LATEST POST-OPERATIVE EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX KNEE SYSTEM TIBIAL BASEPLATE JWH OMNI LIFE SCIENCE, INC. 6289

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR