BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TOTAL KNEE PROSTHESIS

    MDR report key: 76496 · Received March 12, 1997

    Report

    Report Number
    76496
    Event Type
    Injury
    Date Received
    March 12, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 5, 1997
    Manufacturer
    BIOMET
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE ARTHROPLASTY PERFORMED ON 9/27/96. PT RETURNED TO SURGERY FOR REMOVAL OF LEFT KNEE PROSTHETIC TOTAL JOINT ON 1/24/97 DUE TO INFECTION OF THE LEFT KNEE. ADD'L CAT#: 11-150830. ADD'L LOT #: 816330, 273310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TOTAL KNEE PROSTHESIS Implant TOTAL KNEE PROTHESIS JWH BIOMET * 063770, 625890, 279820

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R