BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORIN BIPOLAR

    MDR report key: 72126 · Received February 25, 1997

    Report

    Report Number
    9614209-1997-90001
    Event Type
    Other
    Date Received
    February 25, 1997
    Date of Event
    January 23, 1997
    Report Date
    February 24, 1997
    Manufacturer
    CORIN MEDICAL LTD
    Product Code
    KWB
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WHO RECEIVED A STEM AND BIPOLAR SUBSEQUENTLY PRESENTED WITH AN ANATOMIC DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED BY A RESIDENT WHO CAUSED A PROSTHETIC DISLOCATION. THIS ACTION IS STRICTLY CONTRAINDICATED IN THE BIPOLAR PRODUCT INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORIN BIPOLAR Implant BIPOLAR (HIP) KWB CORIN MEDICAL LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention