BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9612771-2006-00023

    MDR report key: 763857 · Received September 1, 2006

    Report

    Report Number
    9612771-2006-00023
    Event Type
    Injury
    Date Received
    September 1, 2006
    Product Code
    KWY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO DEVICES HAVE BEEN RETURNED TO PLUS ORTHOPEDICS USA SO AN EVAL CANNOT BE PERFORMED. CONCLUSIONS: THE SURGEON HAS INDICATED TO PLUS ORTHOPEDICS, THAT HE DOES NOT BELIEVE PLUS PRODUCTS CAUSED OR CONTRIBUTED TO THE PT'S CONDITION. LITERATURE CITATION: ON THE SECOND PAGE OF THE ATTACHED ARTICLE, IN THE SECOND FULL PARAGRAPH THE SURGEON'S OBSERVATION IS, "I EXPERIENCED A SIGNIFICANT LEARNING CURVE WITH 1.2% DISLOCATIONS AND 1.6% REOPERATIONS BUT, SOMEWHAT UNIQUE IN AN EARLY EXPERIENCE OF MIS HIP REPLACEMENT, THERE WERE NO INTRAOPERATIVE FRACTURES AND NO NERVE DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWY

    Patients

    Seq Age Sex Outcome Treatment
    1