BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONX IMPLANT

    MDR report key: 235548 · Received August 6, 1999

    Report

    Report Number
    MW1016916
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Date of Event
    February 4, 1999
    Report Date
    August 6, 1999
    Manufacturer
    BIONX IMPLANTS, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ACUTE EPISODE OF INCREASED PAIN & SUDDEN LOSS OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX IMPLANT Implant BANKART TACK MAI BIONX IMPLANTS, INC. * 178

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other