BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FEMORAL COMPONENT

    MDR report key: 3954851 · Received July 16, 2014

    Report

    Report Number
    3007963827-2014-00030
    Event Type
    Injury
    Date Received
    July 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTS WERE EVALUATED FOR COMPATIBILITY AND FOUND TO BE COMPATIBLE. THE METALS ALLERGY TESTING RESULTS PROVIDED INDICATE THAT THE PATIENT REACTED TO NICKEL AND MOLYBDENUM AND APPEARS TO BE BORDERLINE REACTIVE TO CHROMIUM. THE NEXGEN LPS FEMORAL COMPONENT IMPLANTED CONTAINS COBALT, CHROMIUM AND MOLYBDENUM. IT IS LIKELY THAT THE PATIENT'S ALLERGY TO COBALT, CHROMIUM AND MOLYBDENUM ARE THE CAUSE OF THE PATIENT'S PAIN; HOWEVER, THIS CANNOT BE DETERMINED DEFINITIVELY. REVIEW OF THE DEVICE HISTORY RECORDS 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND POSSIBLE ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415877 NEXGEN LPS FEMORAL COMPONENT NJL ZIMMER ORTHOPEDIC MFG LTD 61972749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other