BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATH(R) THREAD CUP ADAPTOR

    MDR report key: 3827813 · Received May 22, 2014

    Report

    Report Number
    3010536692-2014-00857
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY AFTER IMPACTION OF THE DYNASTY CUP THE THREADED CUP ADAPTER BECAME STUCK OF THE SUPER CAP CUP IMPACTOR. PREVENTING REMOVAL OF THE SUPER PATH CUP IMPACTOR THROUGH THE DRIVE SHAFT CANNULA. DR ANDERSON HAS DONE A 1000 PLUS PATH PROCEDURES THIS WAS THE SECOND TIME THIS PROBLEM OCCURRED BOTH IN THE PAST TWO WEEKS ALL USING THE NEW SUPER PATH INSTRUMENT SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305312 PATH(R) THREAD CUP ADAPTOR HIP INSTRUMENT KWA MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1