BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGP II ACETABULAR COMPONENTS BONE SCREW SELF-TAPPING

    MDR report key: 338847 · Received June 20, 2001

    Report

    Report Number
    1822565-2001-00041
    Event Type
    Injury
    Date Received
    June 20, 2001
    Date of Event
    February 10, 1999
    Report Date
    May 21, 2001
    Manufacturer
    ZIMMER, INC.
    Product Code
    NDJ
    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 1997 PT UNDERWENT RIGHT TOTAL HIP REPLACEMENT. SEVERAL YEARS LATER, ON EVENT DATE, X-RAYS REVEALED THAT THE TWO SCREWS SECURING THE ACETABULAR SHELL HAD FRACTURED AND THAT THE SHELL HAD ROTATED INTO VERTICAL POSITION. FOLLOWING, IN 1999, PT UNDERWENT REVISION OF THE HIP WHERE THE ACETABULAR CUP AND SCREWS WERE REMOVED AND REPLACED WITH A NEW 56 MM HGP II ACETABULAR CUP, ELEVATED RIM LINER AND TWO 30 MM SCREWS. PT'S RECOVERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28260 HGP II ACETABULAR COMPONENTS BONE SCREW SELF-TAPPING HIP PROSTHESIS NDJ ZIMMER, INC. NA 13712800

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R