BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LT TOTAL KNEE PROSTHESIS

    MDR report key: 391025 · Received April 30, 2002

    Report

    Report Number
    391025
    Event Type
    Injury
    Date Received
    April 30, 2002
    Date of Event
    February 27, 2002
    Report Date
    March 12, 2002
    Manufacturer
    BIOMET, INC.
    Product Code
    KRQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH DIAGNOSIS OF LOOSE LT TOTAL KNEE PROSTHESIS. THE PT HAD A LONG COMPLEX PROBLEM INVOLVING THEIR KNEES. IN 1982 PT UNDERWENT LT TOTAL KNEE ARTHROPLASTY, AFTERWARD SUFFERED PERSISTENT STAPH INFECTION. IN 1992, PT UNDERWENT REVISION THEN AFTER DEVELOPED SERRATIA OF MARCESCENS, REQUIRED REMOVAL OF PROSTHESIS IN 1998 AND 8-10 WKS IF ANTIBIOTICS. FIVE MONTHS LATER PT UNDERWENT REVISION WITH A THIN ROTATING HINGE PROSTHESIS. THE PT DID INITIALLY WELL BUT STARTED TO HAVE MORE PAIN AND INSTABILITY. PT'S PAIN WAS LOCATED IN THE REGION OF THE THIGH REQUIRING A WALKER TO AMBULATE. IN 2002, PT UNDERWENT REVISION OF LT KNEE REPLACEMENT. INTRA-OPERATIVE PER SURGEON NOTED FEMORAL COMPONENT TO HAVE ROTATION BETWEEN THE END OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LT TOTAL KNEE PROSTHESIS KNEE COMPONENTS KRQ BIOMET, INC. X *
    2 LT TOTAL KNEE PROSTHESIS KNEE COMPONENT KRQ BIOMET INC CP110377 *
    3 LT TOTAL KNEE PROSTHESIS KNEE COMPONENTS KRQ BIOMET, INC B077100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization