BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER BRAND ADVANTIM LSI TIBIAL INSERT

    MDR report key: 104813 · Received July 8, 1997

    Report

    Report Number
    1043534-1997-00095
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    June 1, 1997
    Report Date
    July 7, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: UPON FURTHER INVESTIGATION, IT WAS FOUND BY THE USER FACILITY THAT CO PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THIS SERIOUS INJURY; THEREFORE, THE MDR WAS NOT REQUIRED.

    Description of Event or Problem · 1

    PT ALLEGEDLY HAD DISTAL FRACTURE OF FEMUR. A TIBIAL ROD PROCEDURE WAS PERFORMED AND INSERT WAS REMOVED DURING THIS PROCEDURE. AT TIME OF REMOVAL, SURGEON ALLEGEDLY SAW EXTREME WEAR (PITTING) OF THE TIBIAL INSERT. HE SAID HE DID NOT SEE ANY LOOSE BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER BRAND ADVANTIM LSI TIBIAL INSERT Implant KNEE COMPONENT KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 095A030631

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO