BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM EPOCH FULLCOAT HIP PROSTHESIS FEMORAL STEM

    MDR report key: 1113152 · Received August 12, 2008

    Report

    Report Number
    1822565-2008-00506
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    April 19, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PT INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. THE FOLLOWING MONTH, THE PT PRESENTED WITH A SUPERFICIAL HEMATOMA INFECTION RESULTING IN A HEAD AND MODULAR NECK CHANGE, WASHOUT, AND ANTIBIOTICS TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM EPOCH FULLCOAT HIP PROSTHESIS FEMORAL STEM HIP PROSTHESIS JDI ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R