BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS PRECOAT FEMORAL COMPONENT

    MDR report key: 5727496 · Received June 15, 2016

    Report

    Report Number
    0001822565-2016-02037
    Event Type
    Injury
    Date Received
    June 15, 2016
    Report Date
    January 16, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP060037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - ZIMMER NEXGEN TIBIAL PLATE COMPONENT CATALOG #: 00-5980-047-02 LOT #: NI, ZIMMER NEXGEN PATELLA CATALOG #: 00-5972-065-32 LOT #: NI, ZIMMER NEXGEN ARTICULAR SURFACE CATALOG #: 00-5964-040-10 LOT #: NI. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 1 OF 2 FOR THIS PATIENT. SEE ALSO 0001822565-2017-00255. THE LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW IDENTIFIED NO OTHER COMPLAINTS FOR PART 00-5990-015-02 RELATED TO RANGE OF MOTION ISSUES AND CLICKING. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. PER THE CURRENT NEXGEN CR-FLEX AND LPS-FLEX KNEE PACKAGE INSERT AT THE TIME OF THE PRIMARY SURGERY, POOR RANGE OF MOTION AND PAIN ARE KNOWN RISKS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING, A CLICKING NOISE, AND LOSS OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381433 NEXGEN LPS PRECOAT FEMORAL COMPONENT KNEE PROSTHESIS NJL ZIMMER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other