BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 414990 · Received September 5, 2002

    Report

    Report Number
    1822565-2002-00122
    Event Type
    Injury
    Date Received
    September 5, 2002
    Date of Event
    October 18, 2000
    Report Date
    August 21, 2002
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT IN 1999 PATIENT UNDERWENT REVISION OF A 1995 RIGHT TOTAL HIP ARTHROPLASTY. A NEW HGP II SHELL AND LINER WERE PLACED. FOLLOWING THE PROCEDURE, PATIENT'S DIFFICULTIES PERSISTED AND THE HIP WAS AGAIN REVISED IN 2000 WHERE THE IMPLANTS WERE FOUND TO EVIDENCE MICRO-MOTION RELATED TO FAILED BONY INGROWTH POSTERIOR TO THE SHELL AND THE LINER WAS FOUND IN RETROVERTED POSITION. THE FEMORAL HEAD, SHELL AND LINER WERE ALL REVISED USING HOWMEDICA AND OSTEONICS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER HGP II ACET CUP MOD POR SHELL KWB ZIMMER, INC. NA 43578100

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R