BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONDYLAR PROSTHESIS

    MDR report key: 28959 · Received July 11, 1995

    Report

    Report Number
    28959
    Event Type
    Injury
    Date Received
    July 11, 1995
    Date of Event
    January 5, 1995
    Report Date
    July 7, 1995
    Manufacturer
    OSTEO MED CORP.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURED RIGHT METAL CONDYLAR PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONDYLAR PROSTHESIS CONDYLAR PROSTHESIS JWH OSTEO MED CORP. ASTM F-136, ASTM F-799

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention