BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARRIS GALANTE TOTAL HIP ACETABULAR SHELL AND LINER

    MDR report key: 294098 · Received August 29, 2000

    Report

    Report Number
    1822565-2000-00072
    Event Type
    Injury
    Date Received
    August 29, 2000
    Date of Event
    July 11, 1995
    Report Date
    July 31, 2000
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    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

    IN 87, PT UNDERWENT A THIRD REVISION OF RIGHT TOTAL HIP, PLACING A ZIMMER HGP SHELL AND LINER, BIAS FEMORAL STEM AND A FEMORAL HEAD. MID 1995, PT BEGAN COMPLAINING OF "SNAPPING" IN THE RIGHT HIP AND FLUROSCOPY REVEALED DISLOCATION OF THE HIP WITH ADDUCTION. A COUPLE MONTHS LATE, PT UNDERWENT REVISION OF THE RIGHT HIP WHERE THE ACETABULAR LINER AND FEMORAL STEM WERE REPLACED, USING A NEW, UNIDENTIFIED ZIMMER ACETABULAR LINER AND A RICHARDS FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARRIS GALANTE TOTAL HIP ACETABULAR SHELL AND LINER HIP PROSTHESIS JDI ZIMMER, INC. NA 52114300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention