BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LUBRIMET

    MDR report key: 2971636 · Received February 21, 2013

    Report

    Report Number
    9613369-2013-00013
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    SMITH&NEPHEW -SWITZERLAND
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED VIA A CLINICAL STUDY THAT 64 REVISIONS TOOK PLACE AT THE HOSPITAL IN (B)(6)BETWEEN 2002-2012. THE REVISIONS CONSISTED OF REPLACING THE PE ACETABULAR LINER FOR WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75369 HI-LUBRIMET PE ACETABULAR LINER KWZ SMITH&NEPHEW -SWITZERLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HI SHELL -ACETABULAR SHELL| KS FEMORAL STEM| METAL BALL HEAD -FEMORAL HEAD COMPONENT