BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5428364 · Received February 10, 2016

    Report

    Report Number
    3007963827-2016-00008
    Event Type
    Injury
    Date Received
    February 10, 2016
    Report Date
    January 13, 2016
    Manufacturer
    ZIMMER, BUILDING #2
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO PRODUCT WAS RETURNED, THE CONDITION OF THE IMPLANTS ASSOCIATED WITH THIS COMPLAINT IS UNKNOWN. THE COMPONENTS INVOLVED WERE VERIFIED FOR COMPATIBILITY WITH NO ISSUES NOTED. THESE DEVICES ARE USED FOR TREATMENT. IT CAN NOT BE DETERMINED WHETHER ALL COMPONENTS WERE IMPLANTED ACCORDING TO APPROVED SURGICAL TECHNIQUE. PER REQUEST, INFORMATION ABOUT THE CHEMICAL COMPOSITION OF NEXGEN IMPLANTS WAS SENT TO THE PATIENT'S DOCTOR. THE PACKAGE INSERT PROVIDED STATES INFLAMMATION, SWELLING, AND METAL SENSITIVITY ARE POSSIBLE ADVERSE EFFECTS OF IMPLANTATION OF THIS SYSTEM. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) OTHER DEVICE USED: CATALOG #00598003702, NEXGEN STEMMED PRECOAT TIBIAL COMPONENT, LOT #63135797; MANUFACTURED AT ZIMMER B.V., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER SURGERY THE PATIENT WAS HOSPITALIZED DUE TO ANGINOEDERM AND IDIOPATHIC URTICARIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84558 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH JWH ZIMMER, BUILDING #2 63188066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other