BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEONICS C-TAPER HEAD

    MDR report key: 381481 · Received March 6, 2002

    Report

    Report Number
    2243265-2002-00021
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Date of Event
    February 10, 2002
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    JDH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT WOULD NOT "LOCK" IN PLACE, IMPLANT WAS REMOVED. TRUNION WAS DRIED WITH A LAB SPONGE. SURGEON ATTEMPTED AGAIN TO "LOCK" ON THE HEAD WITH IMPACTION. IT WOULD NOT "HOLD" AND WAS REMOVED BY HAND. NO ADVERSE CONSEQUENCE FOR THE PATIENT OR EXTENSION OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEONICS C-TAPER HEAD IMPLANT JDH HOWMEDICA OSTEONICS NA 74742901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other