BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 2705442 · Received August 16, 2012

    Report

    Report Number
    2648920-2012-00164
    Event Type
    Malfunction
    Date Received
    August 16, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 18, 2012
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR REVIEW, SO THE CONDITION OF THE COMPONENT AND PACKAGING MATERIALS IS UNK. THE CORRECT NUMBERS OF PACKAGING SUBCOMPONENTS WERE DISPATCHED TO THIS LOT (SMALL POLY BAGS, STOCKINETTES, INNER CAVITIES, CAVITY RETAINERS, AND OUTER CAVITIES). FURTHER, THE CORRECT NUMBER OF PACKAGE INSERTS AND PT LABELS WERE DISPATCHED. IT IS UNLIKELY THAT ALL SEVEN PACKAGING COMPONENTS THAT WERE ASSEMBLED BY THREE SEPARATE OPERATORS WOULD HAVE BEEN MISSING FROM THE CARTON. IT IS LIKELY THAT THE PRODUCT WAS OPENED AT SOME POINT, ALTERED, AND THEN PUT BACK IN INVENTORY IN THE FIELD. IT IS UNK AT WHICH POINT THIS WOULD HAVE OCCURRED. EVAL: REVIEW OF THE DEVICE HISTORY DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING THE DEVICE, THE STERILE BARRIER WAS NOT IN PLACE AND THE DEVICE WAS JUST PLACED IN THE BOX WITHOUT ANY BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL HEAD LPH ZIMMER 62016721

    Patients

    Seq Age Sex Outcome Treatment
    1