BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFORM. POROUS FEMORAL

    MDR report key: 106653 · Received July 17, 1997

    Report

    Report Number
    1825034-1997-00054
    Event Type
    Other
    Date Received
    July 17, 1997
    Report Date
    July 15, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO CO FROM A FOREIGN COMPANY REP. THE DEVICE WAS EXPLANTED FOR UNK REASONS. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORM. POROUS FEMORAL Implant PROSTHESIS, KNEE, COMP. HSA BIOMET, INC. NA 888R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention