BEUDAMED
    FDA Adverse Event Other Summary report: N

    AGC MOD TIB II FIN. STEM

    MDR report key: 206392 · Received January 15, 1999

    Report

    Report Number
    1825034-1999-00004
    Event Type
    Other
    Date Received
    January 15, 1999
    Date of Event
    December 8, 1998
    Report Date
    January 13, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON 5/17/96. REVISION SURGERY WAS PERFORMED ON 12/8/98. UPON REMOVAL OF DEVICES, PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC MOD TIB II FIN. STEM Implant PROSTHESIS, KNEE, COMP. HSH BIOMET, INC. NA 339460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other