BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 2934317 · Received January 11, 2013

    Report

    Report Number
    2648920-2013-00031
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. ADDITIONALLY, THIS DEVICE WAS PACKAGED IN A CLASS 10,000 CLEAN ROOM, UNDER A SPECIALLY DESIGNED HOODED PACKAGING STATION THAT CREATES A CLASS 1000 CLEAN ROOM ENVIRONMENT THAT SIGNIFICANTLY REDUCES THE PRESENCE OF FOREIGN CONTAMINANTS. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE PRESENCE OF THE FOREIGN MATERIAL FOUND IN THE PACKAGE WILL LEAD TO ANY INFECTION OR OTHER BIO-INCOMPATIBILITY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS OPENED AND A PIECE OF HAIR WAS INSIDE THE STERILE PACKAGE. WITH NO BACK UP IMPLANTS AND THE ASSUMPTION THAT THE HAIR WAS STERILE, THE HEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19316 VERSYS FEMORAL HEAD JDI ZIMMER 62180228

    Patients

    Seq Age Sex Outcome Treatment
    1