BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROCARE

    MDR report key: 1032557 · Received April 23, 2008

    Report

    Report Number
    1032557
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ARTHROCARE SPORTS MEDICINE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR LEFT KNEE ARTHROSCOPY AND OSTECTOMY SECONDARY TO ARTHROFIBROSIS AND HETEROTOPIC OSTEOPHYTE FORMATION STATUS LEFT TOTAL KNEE ARTHROPLASTY. THE SURGEON USED THE ARTHROWAND TO DEBRIDE AROUND THE OSTEOPHYTE. HE USED THE DEVICE FOR FIFTY MINUTES. AT THE END OF THIS INTERVAL, THE BASEPLATE ON THE ARTHROWAND WAS FOUND IN TWO PIECES. THE SURGEON REMOVED THE SMALLER PIECES WHICH REPRESENTED ONE THIRD OF THE DEVICE WITHOUT INCIDENCE. THE LARGER PIECE, REPRESENTING TWO THIRDS OF THE DEVICE, FRAGMENTED WHEN IT WAS REMOVED. THE SURGEON BELIEVED THAT HE HAD REMOVED 50% OR MORE OF THE DISK. THE REMAINDER COULD NOT BE FOUND. THE KNEE WAS THEN LAVAGED. JUST TO SEE IF AN ARTHROWAND WOULD BE VISIBLE UNDER THE C-ARM, IT WAS TESTED AS SUCH AND THE DISK DISTALLY WAS BARELY VISIBLE ON THE C-ARM. THE SURGEON CONDUCTED A VISUAL EXAMINATION OF THE KNEE FOR RETAINED ARTHROWAND PIECES UNDER FLUOROSCOPY AND HE WAS UNABLE TO IDENTIFY ANY METALLIC FOREIGN BODY. THE KNEE WAS ONCE AGAIN LAVAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE ARTHROWAND TURBOVAC HRX ARTHROCARE SPORTS MEDICINE UNK V227770-A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention