BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JWH

    MDR report key: 5566238 · Received April 10, 2016

    Report

    Report Number
    1822565-2016-01082
    Event Type
    Malfunction
    Date Received
    April 10, 2016
    Date of Event
    April 7, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Removal / Correction Number
    Z-0845-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE PRODUCT WAS NOT RETURNED FOR REVIEW, THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. THIS DEVICE IS USED FOR TREATMENT. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND AS PART OF CORRECTIVE ACTION, A NEW SUPPLIER FOR THE POLYETHYLENE BAGS HAS BEEN SELECTED AND TESTING COMPLETED TO ENSURE THERMAL RELIABILITY AND STABILITY OF THE NEW BAGS. FIELD ACTION Z-0845-2016 WAS INITIATED ON JANUARY 11, 2016 TO REMOVE REMAINING AFFECTED UNITS FROM THE FIELD. THIS FIELD ACTION CONTAINS THE RELATED PART AND LOT NUMBER. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PLASTIC FILM WAS OBSERVED ON AREAS OF THE FEMORAL COMPONENT. THE FILM WAS REMOVED WITH STERILE WATER AND THE COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221656 JWH JWH ZIMMER INC 62103519

    Patients

    Seq Age Sex Outcome Treatment
    1