BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 10419572 · Received August 18, 2020

    Report

    Report Number
    10419572
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    August 30, 2019
    Report Date
    August 10, 2020
    Manufacturer
    TECRES S.P.A.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION OF RIGHT TOTAL HIP REPLACEMENT WITH MOBILE BEARING ACETABULAR COMPONENT, OPEN REDUCTION INTERNAL FIXATION OF PERIPROSTHETIC FEMUR FRACTURE; REMOVAL OF ANTIBIOTIC SPACER DEBRIDEMENT OF RIGHT HIP JOINT AND FEMUR; APPLICATION OF NEGATIVE PRESSURE WOUND DRESSING DUE TO RECURRENT PERIPROSTHETIC FRACTURE RIGHT FEMUR INVOLVING ANTIBIOTIC SPACER. THE SPACER HAS BEEN IN PLACE APPROXIMATELY FOR 4 MONTHS TREATING A CANDIDA LUSITANIAE AND ENTEROBACTER INFECTION OF A RIGHT TOTAL HIP REPLACEMENT THE SPACER WAS IMPREGNATED WITH VORICONAZOLE AND AMPHOTERICIN AND ANTI-BACTERIAL ANTIBIOTICS AS WELL. PATIENT ALSO UNDERWENT 2 PER-OPERATIVE ASPIRATIONS APPROXIMATELY A MONTH APART, BOTH OF WHICH HAVE BEEN PROVEN NEGATIVE FOR INFECTION OF BACTERIA AND NEGATIVE FOR FURTHER INFECTION WITH CANDIDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883471 EXACTECH PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER KWY TECRES S.P.A. AA9746035

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Required Intervention