BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORELAND

    MDR report key: 1943998 · Received December 15, 2010

    Report

    Report Number
    1943998
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING WELL-FIXED CEMENT FROM WITHIN THE CANAL AND ONCE THE CEMENT RESTRICTOR WAS ALSO REMOVED, IT WAS NOTED THAT THE MORELAND INSTRUMENT (ONE OF THE SMALL HOOKS) WAS MISSING ITS TIP AFTER THIS EXTRACTION DEVICE WAS USED. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE MISSING TIP. POST-OPERATIVE RADIOGRAPH REVEALED FILM THAT WAS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORELAND CEMENT EXTRACTOR JDY DEPUY ORTHOPAEDICS, INC. 602012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR