BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS UNIVERSAL HINGE

    MDR report key: 2221025 · Received August 23, 2011

    Report

    Report Number
    1020279-2011-00339
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS MEASURED AND THE WIDTH OF MEDIAL GEAR BASE ASSEMBLY WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PART ROTATES WITH MINIMAL EFFORT AND DOES NOT BIND DURING OPERATION. THE REPORTED FAILURE MODE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED AFTER THE SURGEON WAS UNHAPPY WITH THE HINGE'S FLUIDITY AND RANGE OF MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPASS UNIVERSAL HINGE COMPASS UNIVERSAL HINGE KTT SMITH & NEPHEW, INC. 71060001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)| (B)(4)