BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5982787

    MDR report key: 5982787 · Received September 28, 2016

    Report

    Report Number
    5982787
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 20, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING STERILE IMPLANT, IT WAS DISCOVERED THAT THE INCORRECT PRODUCT HAD BEEN INSERTED INTO THE PACKAGE BOX. THE PACKAGING WAS LABELED AS DUAL MOBILITY BEARING, THE INTENDED IMPLANT WAS A DUAL MOBILITY BEARING BUT PACKAGE CONTAINED A SINGLE MOBILITY BEARING. THIS WAS DISCOVERED PRIOR TO PLACING THE IMPLANT IN THE PATIENT. THE IMPLANT AND PACKAGING WERE REMOVED FROM THE OR. THIS DID NOT CAUSE PATIENT HARM, AS THE CORRECT DEVICE WAS BROUGHT TO THE OR FOR IMPLANTATION. NO CONTACT OR HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR DUAL MOBILITY BEARING, DUAL MOBILITY BEARING (PER SITE REPORTER): NO RESPONSE TO DATE; A SINGLE MOBILITY BEARING WAS IN A PACKAGE LABELED DUAL MOBILITY BEARING.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR