BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR UNIVERSITY CUP FLANG IMPACTOR

    MDR report key: 317752 · Received February 20, 2001

    Report

    Report Number
    2219689-2001-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2001
    Date of Event
    January 22, 2001
    Report Date
    January 22, 2001
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    HWA
    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

    6302-7-099 UNIVERSAL SHELL IMPACTOR WOULD NOT DISENGAGE WITH THE 6302-2-050 VITOLOCK SOLID BACK CUP AFTER IMPACTION IN ACETABULM CUP WAS REMOVED FROM SOCKET AND A CLUSTER SHELL OF THE SAME SIZE WAS USED. IT WAS PUT IN WITH AN OLD STYLE IMPACTOR. THE SURGERY WAS COMPLETED WITH GOOD RESULTS. SURGERY DELAY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6628 ACETABULAR UNIVERSITY CUP FLANG IMPACTOR INSTRUMENT HWA HOWMEDICA OSTEONICS NA AOL1885

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other