BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCIA PLASMAPORE-UCAP 8/10 SIZE 13MM

    MDR report key: 859600 · Received June 1, 2007

    Report

    Report Number
    3005673311-2007-00028
    Event Type
    Injury
    Date Received
    June 1, 2007
    Date of Event
    April 20, 2007
    Report Date
    May 30, 2007
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, INC.
    Product Code
    JDI
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR MFR, AESCULAP, HAS PROVIDED FURTHER ANALYSIS. REMARK : THE REASON OF THE BREAKAGE WAS THE COMBINATION OF AN AESCULAP HIP STEM WITH BIOLOX HEAD WITH A CUP AND INSERT OF A COMPETITOR. THIS COMBINATION IS NOT APPROVED BY AESCULAP AND CLASSIFIED AS A USER ERROR. A SAMPLE WAS NOT RETURNED FROM THE USER/FACILITY, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. ALTHOUGH, IT WAS NOTED THAT THE CUSTOMER USED AN AESCULAP STEM WITH A CUP AND INSERT OF A COMPETITOR. OUR AESCULAP IMPLANT SYSTEMS (AIS) INSTRUCTIONS FOR USE 834 / EXIA HIP SYSTEM PACKAGE INSERT: STATES THAT THIS COMBINATION IS NOT APPROVED: UNDER 1) WARNINGS AND POTENTIAL RISKS: THE MIXING OF DIFFERENT MANUFACTURER IMPLANT COMPONENTS IS NOT RECOMMENDED DUE TO METALLURGICAL, MECHANICAL AND FUNCTIONAL REASONS. DISSIMILAR METALS IN CONTACT WITH EACH OTHER CAN ACCELERATE THE CORROSION PROCESS DUE TO GALVANIC CORROSION EFFECTS. DO NOT USE IMPLANTS OR INSTRUMENTS FROM OTHER SYSTEMS OR MANUFACTURERS. 2) DIRECTIONS FOR USE: TO IMPLANT THE EXCIA IMPLANTS, USE ONLY THE SPECIALIZED EXCIA INSTRUMENTATION. DO NOT USE IMPLANTS OR INSTRUMENTS FROM ANY OTHER SYSTEM OR MANUFACTURER. SHOULD THE SAMPLE BECOME AVAILABLE THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    INCIDENT OUTSIDE OF THE USA. INCIDENT OF SURGERY: BREAK OF EXCIA STEM. DATE OF INCIDENT: 2007. TYPE OF SURGERY: HIP OPERATION. REVISION SURGERY PERFORMED. THE BREAKAGE WAS CAUSED BY A NOT ALLOWED COMBINATION WITH A CUP OF A COMPETITOR. THE ITEM WAS NOT RECEIVED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIA PLASMAPORE-UCAP 8/10 SIZE 13MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, M JDI AESCULAP IMPLANT SYSTEMS, INC. NA 51105659

    Patients

    Seq Age Sex Outcome Treatment
    1 YR