BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARGRON STEM (K032641)

    MDR report key: 609469 · Received May 31, 2005

    Report

    Report Number
    9613642-2005-00001
    Event Type
    Injury
    Date Received
    May 31, 2005
    Manufacturer
    PORTLAND ORTHOPAEDICS PTY LTD
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AGGREGATE DATA SUGGEST THAT USE OF THE MARGRON STEM IN SOFT BONE OR STOVE PIPE BONE PRIMARY PROCEDURES MAY CREATE A HIGHER-THAN-AVERAGE POSSIBILITY OF THE NEED FOR REVISION SURGERY. DATA INDICATE THAT DEVICES ARE NOT DEFECTIVE AND DID NOT CAUSE OR CONTRIBUTE TO THE NEED FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARGRON STEM (K032641) CEMENTLESS STEM FOR HIP REPLACEMENT KWY PORTLAND ORTHOPAEDICS PTY LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *