BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIST HEMIARTHROPLASTY SYSTEM

    MDR report key: 10237851 · Received July 6, 2020

    Report

    Report Number
    3004154314-2020-00003
    Event Type
    Injury
    Date Received
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWN
    PMA / PMN Number
    K141920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AN APPROPRIATE ROOT CAUSE FOR THE REPORTED INFECTION CANNOT BE ASCERTAINED WITH THE INFORMATION AVAILABLE. ACCORDING TO THE REP, THE WRIST MOTION IMPLANT LOOKED GOOD AND WITHOUT ANY ISSUES AT THE TIME OF THE REVISION. IT IS UNKNOWN WHETHER A PATH/ CULTURE TEST WAS PERFORMED TO DETERMINE THE SOURCE OF THE INFECTION BUT THE HOSPITAL NEVER RESPONDED. AS A RESULT, THE SOURCE OF INFECTION CANNOT BE TRACED OR CONFIRMED. THERE IS NOT ENOUGH INFORMATION ON THE EXPLANTED DEVICE WITHOUT WHICH AN INVESTIGATION COULD NOT BE CONDUCTED. THERE ARE NO REPORTS CONCERNING DEVICE STERILITY AMONG WRIST MOTION DEVICES (LOTS) MANUFACTURED TO DATE. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT LISTS ALL POSSIBLE ADVERSE EFFECTS AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC., CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. THE PATIENT WAS REVISED TO AN ANTIBIOTIC SPACER FOLLOWED BY THE FUSION OF THE WRIST. THE PATIENT NO LONGER HAS ARTHROSURFACE IMPLANTS. SHOULD ARTHROSURFACE RECEIVE ANY FURTHER INFORMATION REGARDING THIS REVISION, IT WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED VIA A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    A PATIENT WITH ARTHROSURFACE WRIST MOTION IMPLANT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695431 WRIST HEMIARTHROPLASTY SYSTEM PARTIAL WRIST JOINT KWN ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other