BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 110177 · Received July 30, 1997

    Report

    Report Number
    59396-1997-00001
    Event Type
    Injury
    Date Received
    July 30, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 17, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF PAIN. X-RAYS REVEALED DEVICE HAD FRACTURED REQUIRING REVISION SURGERY TO REMOVE AND REPLACE OTHER DEVICE. REMOVED AND REPLACED 00-5110-043-09 MGII KNEE TIBIAL ARTICULAR SURFACE LOT NO, 79325500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant MGII TIBIAL PLATE AND SURFACE HSH ZIMMER, INC. NA 42226100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention