BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER SAW BLADE

    MDR report key: 2804222 · Received October 21, 2012

    Report

    Report Number
    MW5027338
    Event Type
    Injury
    Date Received
    October 21, 2012
    Date of Event
    June 27, 2011
    Report Date
    October 21, 2012
    Manufacturer
    BRASSELER USA
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) UNDERWENT A TOTAL ARTHROPLASTY OF THE LEFT KNEE DUE TO SEVERE OSTEOARTHRITIS WITH NECROSIS, BONE EDEMA IN THE MEDIAL FEMORAL CONDYLE AND TIBIAL PLATEAU. SURGERY WAS PERFORMED AFTER UNSUCCESSFUL NON SURGICAL TREATMENT OUTCOMES, INCLUDING CORTICOSTEROID INJECTIONS X 3, SYNVISC INJECTION, PHYSICAL THERAPY, AND ACUPUNCTURE. THE SURGERY INVOLVED BIOMET KNEE REPLACEMENT USING AN 83MM TIBIAL TRAY WITH A 75MM FEMUR, A LARGE PATELLA AND A 12MM SPACER. ALL COMPONENTS WERE CEMENTED IN PLACE WITH ANTIBIOTIC CEMENT. THREE BRASSELER KM71-563 BLADES WERE USED FOR APPROPRIATE CUTS IN THE FEMUR, TIBIA AND PATELLA. THE OPERATING SURGEON REMARKED TO (B)(6) THAT HE HAD NEVER USED THREE BLADES WITH THIS TYPE OF SURGERY. (B)(6) WAS HOSPITALIZED FOR TWO NIGHTS AFTER THE SURGERY. ON (B)(6) 2012, (B)(6) UNDERWENT A REVISION ARTHROTOMY OF THE LEFT KNEE DUE TO PERSISTENT SWELLING, PAIN AND INABILITY TO RESUME HIS NORMAL ACTIVITIES. THE SURGERY CONSISTED OF ARTHROTOMY AND SYNOVECTOMY OF THE LEFT KNEE, CULTURE AND SENSITIVITY OF THE SOFT TISSUE WITH MICROSCOPIC ANALYSIS OF THE SYNOVIUM, AND EXCHANGE OF THE POLY LINER FROM A 12 TO A 14MM LINER. POST OPERATIVE DIAGNOSIS WAS SYNOVITIS OF THE LEFT KNEE WITH WHAT APPEARED TO BE METAL DEBRIS IN THE CONFINES OF THE KNEE, I.E. METALLOSIS. (B)(6) WAS HOSPITALIZED FOR ONE NIGHT AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER SAW BLADE BRASSELER SAW BLADE GFA BRASSELER USA KM71-563 UNK
    2 BIOMET TOTAL KNEE REPLACEMENT TIBIAL PLATE JWH BIOMET ORTHOPEDICS J100915110
    3 BIOMET TOTAL KNEE REPLACEMENT 12 79X83 BEARING JWH BIOMET ORTHOPEDICS EP-183662 920600
    4 BIOMET TOTAL KNEE REPLACEMENT 37 PATELLA JWH BIOMET ORTHOPEDICS 903180
    5 BIOMET TOTAL KNEE REPLACEMENT 75 PS FEMUR JWH BIOMET ORTHOPEDICS 966440

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other