BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXTSTEP ARTHROPEDIX

    MDR report key: 7143696 · Received December 22, 2017

    Report

    Report Number
    3002498892-2017-00006
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    September 5, 2017
    Report Date
    December 22, 2017
    Manufacturer
    THEKEN COMPANIES
    Product Code
    LPH
    UDI-DI
    00816127022494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPE DISINFECTION POST OPERATIVELY. SURGEON SCHEDULED A COMPLETE EXPLANTATION, IRRIGATION AND DEBRIDEMENT, ANTIBIOTICS AND REPLACEMENT IMPLANTS. THERE IS NO INDICATION OF A MALFUNCTION OF THE IMPLANTS AND A SOURCE OF THE INFECTION WAS NOT DETERMINED. ALL 4 COMPONENTS WERE REPLACED. ORIGINAL IMPLANTED DEVICES WERE FEMORAL HEAD 10-21-3601; LOT # 7011138738, FEMORAL STEM 10-11-0007; LOT # 1087, ACETABULAR CUP 10-32-0058; LOT # 1034, ACETABULAR LINER 10-40-3658; LOT # 1060. THESE LOT NUMBERS WERE COMPARED FOR PREVIOUS COMPLAINTS ON INFECTION. THESE PRODUCT LOTS ARE DIFFERENT. NO LOTS MATCHED. THEREFORE, THERE IS NO REASON TO SUSPECT ANY ISSUES WITH PRODUCT CONTAMINATION. EXACT CAUSE OF INFECTION IS UNKNOWN.

    Description of Event or Problem · 1

    PATIENT HIP SYSTEM WAS REVISED DUE TO INFECTION. COMPLETE WASHOUT, COMPLETE EXPLANTATION AND REIMPLANTATION OF NEW COMPONENTS ALONG WITH ANTIBIOTIC POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922807 NEXTSTEP ARTHROPEDIX INSITU HIP SYSTEM LPH THEKEN COMPANIES 10-21-3601 7011138738 00816127022494

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening