BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 120719 · Received September 15, 1997

    Report

    Report Number
    59415-1997-00007
    Event Type
    Injury
    Date Received
    September 15, 1997
    Date of Event
    July 10, 1997
    Report Date
    September 12, 1997
    Manufacturer
    ZIMMER INC.
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING FOLLOW-UP X-RAY IT WAS NOTICED THAT THE CABLES HAD BROKEN AND FRAYED REQUIRING RE-OPERATION. OLD CABLES WERE REMOVED AND NEW WERE IMPLANTED. IMPLANTS INVOLVED: 1EA. 2232-03-01 LOT #78876000 CABLE PLATE, 1EA. 2232-03-18 LOT #00471100 CABLE WIRE, 2EA. 2232-03-18 LOT #79365800 CABLE WIRE. HOSP DISPOSED OF ITEMS AT TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant CABLE READY SYSTEM JDQ ZIMMER INC. NA 00471100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention