BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 185908 · Received September 3, 1998

    Report

    Report Number
    1822565-1998-00097
    Event Type
    Injury
    Date Received
    September 3, 1998
    Date of Event
    July 28, 1998
    Report Date
    July 30, 1998
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY A MISLABELED NEXGEN KNEE CR POROUS FEMORAL COMPONENT WAS DISCOVERED. THE PRODUCT SHELF CARTON BAR-CODE LABEL INDICATED 00598001402. THE PRODUCT AND ALL OTHER LABELING WERE ACTUALLY 00597201301. SURGERY WAS DELAYED 45 MINUTES WHILE THE CORRECT PRODUCT WAS DELIVERED FROM THE DISTRIBUTOR'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant NEXGEN KNEE POROUS FEMORAL HSA ZIMMER, INC. * 53144800

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention