BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 110611 · Received July 31, 1997

    Report

    Report Number
    59415-1997-00003
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    July 22, 1997
    Report Date
    July 30, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP REPORT UPGRADED FROM PRODUCT PROBLEM TO ADVERSE EVENT REQUIRING INTERVENTION. BROKEN CABLES REMOVED AND REPLACED WITH NEW. ONE EA 2232-03-01 LOT # 76302300, 4 EA 2232-03-18 LOT # 76382700 WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant CABLE-READY PLATE & CABLE SYSTEM FTR ZIMMER, INC. NA 76382700
    2 ZIMMER Implant CABLE-READY PLATE & CABLE SYSTEM HRS ZIMMER, INC. NA 76302300

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention