BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS ACETABULAR SYSTEM

    MDR report key: 2940772 · Received July 14, 2006

    Report

    Report Number
    2530191-2006-00002
    Event Type
    Injury
    Date Received
    July 14, 2006
    Date of Event
    July 11, 2006
    Report Date
    July 13, 2006
    Manufacturer
    STELKAST INC.
    Product Code
    JDG
    PMA / PMN Number
    K001984
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ERROR - THE SURPASS ACETABULAR SYSTEM WAS IMPLANTED WITH A HIP STEM THAT WAS NOT DESIGNED FOR OPTIMAL PERFORMANCE WITH AN ALUMINA CERAMIC FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURPASS ACETABULAR SYSTEM CERAMIC ON CERAMIC HIP SYSTEM JDG STELKAST INC. SC2641-32MM+0 10666-071305

    Patients

    Seq Age Sex Outcome Treatment
    1