BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO

    MDR report key: 145203 · Received January 20, 1998

    Report

    Report Number
    1832656-1998-00001
    Event Type
    Injury
    Date Received
    January 20, 1998
    Date of Event
    August 27, 1997
    Report Date
    January 16, 1998
    Manufacturer
    BIOPRO, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POLYETHYLENE PATELLA BECAME DISASSOCIATED FORM THE PT'S PATELLA. SURGERY WAS REQUIRED TO RECTIFY THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO Implant POLYETHYLENE PATELLA HTG BIOPRO, INC. NA 93-1049

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention