BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRUCIATE RETAINING INSERT

    MDR report key: 1615608 · Received February 19, 2010

    Report

    Report Number
    1038671-2010-00012
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 19, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.

    Description of Event or Problem · 1

    SURGEON USED AN INCORRECT COMBINATION OF IMPLANTS IN A TKR. A SIZE 4 INSERT WAS USED IN COMBINATION WITH A SIZE 5 FEMORAL COMPONENT AND SIZE 5F/4T TRAY. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES IN THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUCIATE RETAINING INSERT TIBIAL INSERT HSH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention