BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL POLY PATELLA

    MDR report key: 4745089 · Received April 27, 2015

    Report

    Report Number
    4745089
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 27, 2015
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXPIRED PATELLA IMPLANT USED IN SURGERY. VENDOR FROM OMNI CONFIRMED IMPLANT SIZE WITH THE PHYSICIAN. STAFF RN LEFT OBTAIN FOOT PEDAL FOR CEMENT MIXER SCUTION. RN HAD TO OPEN IMPLANT AND RECONGNIZED THAT THE PATELLA WAS NOT PRESENT AND BEGAN LOOKING FOR THE BOX. REP PULLED THE IMPLANT OUT OF THE TRASH AND OPENED IT ON THE STERILE FIELD.======================MANUFACTURER RESPONSE FOR ALL POLY PATELLA, ALL POLY PATELLA 3 PEG (PER SITE REPORTER).======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274995 ALL POLY PATELLA PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM JWH OMNI LIFE SCIENCE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR