BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 97357 · Received June 5, 1997

    Report

    Report Number
    33195-1997-00003
    Event Type
    Malfunction
    Date Received
    June 5, 1997
    Date of Event
    February 1, 1997
    Report Date
    May 15, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    X-RAYS REVEALED CABLE BROKE OR PULLED OUT OF THE PLATE - NOT REVISED AT THIS TIME. ITEMS INVOLVED: 1EA. 2232-03-01 LOT#76302300 PLATE. 4EA. 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 JDQ ZIMMER, INC. NA 73623400

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR