BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 166483 · Received May 9, 1998

    Report

    Report Number
    166483
    Event Type
    Injury
    Date Received
    May 9, 1998
    Date of Event
    March 23, 1998
    Report Date
    April 1, 1998
    Manufacturer
    INTERMEDICS ORTHOPEDICS
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN JUNE, 1995, PT HAD A TOTAL HIP REPLACEMENT ON THE LEFT WITH SIGNIFICANT BONE GRAFTING ON THE MEDIAL WALL OF THE ACETABULUM. IN MARCH, 1998, PT STARTED EXPERIENCING A SLIDING, GRATING SENSATION WITH LEFT HIP AND SOME PAIN. X-RAYS REVEALED SEPARATION OF POLY LINER PROTUSIO TYPE FROM THE INGROWN METAL BACK OF THE ACETABULUM COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant ARP INSERT IM PROTUSIO 1433428057 KWB INTERMEDICS ORTHOPEDICS * 0125413

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention