BEUDAMED
    FDA Adverse Event Other Summary report: N

    CROWN CUP

    MDR report key: 3252461 · Received July 23, 2013

    Report

    Report Number
    1038671-2013-00077
    Event Type
    Other
    Date Received
    July 23, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 23, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVAL PENDING DEVICE RETURN.

    Description of Event or Problem · 1

    REVISION AFTER PT FELL AND DISLOCATED. SURGEON INITIALLY PERFORMED A CLOSED REDUCTION BUT THE PT CONTINUED TO DISLOCATE. PT WAS ULTIMATELY REVISED TO A CONSTRAINED LINER AS THE CUP WAS WELL FIXED AND POSITIONED. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342697 CROWN CUP CERAMIC LINER LZO EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R