BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP POLYLINER

    MDR report key: 1035449 · Received April 22, 2008

    Report

    Report Number
    1035449
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 18, 2008
    Report Date
    April 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS RETURNED TO SURGERY FOR A RIGHT HIP REVISION. THE STRYKER ORTHOPAEDICS HIP POLYLINER WAS NOTED TO BE BROKEN. A STRYKER REPRESENTATIVE WAS IN THE OR. THE ORIGINAL SURGERY WAS APPROXIMATELY TWO AND A HALF YEARS PRIOR. THERE HAS BEEN NO RESPONSE FROM THE MANUFACTURER AS OF YET REGARDING THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP POLYLINER ACETABLAR LINER, HIP IMPLANT KWB STRYKER ORTHOPAEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR