BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 3522766 · Received December 5, 2013

    Report

    Report Number
    1822565-2013-01744
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    September 23, 2009
    Report Date
    March 17, 2020
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    PMA / PMN Number
    K991581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. MEDICAL PRODUCTS: LPS-FLEX OPTION FEMORAL G-L; P/N: 00596401701, L/N: 54769200; NEXGEN LPS-MOBILE ARTICULAR SURFACE SIZE G 14MM; P/N: 99594607014, L/N: 70801400; OSTEOBOND BONE CEMENT; P/N: 00110100800, L/N: 5582900; ALL POLY PAT COMP 32DIA; P/N: 00597206532, L/N: 60003654; NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT SIZE 6; P/N: 99594606001, L/N: 69020500. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED FEMUR AND ARTICULAR SHOWS DAMAGES RELATED TO USE LIKE NICKS, GOUGES, WEARS. THE FEMUR DIMENSIONS WERE WITHIN THE SPECIFICATION OF THE PRINT, WHERE MEASURED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER PACKAGE LOOSENING, PAIN, AND INSTABILITY ARE KNOWN ADVERSE EFFECTS OF THIS SYSTEM. WITH UPDATED INFORMATION, NO CHANGE IN THE ROOT CAUSE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631692 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT JWH ZIMMER INC 54769200

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R