BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG I CUP

    MDR report key: 454772 · Received April 17, 2003

    Report

    Report Number
    1822565-2003-00053
    Event Type
    Injury
    Date Received
    April 17, 2003
    Date of Event
    January 6, 2003
    Report Date
    March 21, 2003
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 1995 FOR AN ASEPTIC OSTEONECROSIS OF THE FEMORAL HEAD ON THE RIGHT SIDE. EVERTHING WENT WELL UNTIL THE PATIENT DISLOCATED IN 2001, AND TWICE IN 2002. THE DEVICE WAS REVISED IN 2003. THE PATIENT'S JOB REQUIRES THAT PT WALKS SEVERAL KILOMETERS A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HG I CUP HIP PROSTHESIS KWB ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R