BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC

    MDR report key: 177865 · Received July 16, 1998

    Report

    Report Number
    1822565-1998-00090
    Event Type
    Injury
    Date Received
    July 16, 1998
    Date of Event
    November 25, 1997
    Report Date
    July 10, 1998
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    X-RAYS REVEALED DEBONDING OF CEMENT ALONG THE STEM REQUIRING REVISION SURGERY TO REMOVE AND REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC Implant CENTRALIGN PRECT HIP FEM STEM KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention