BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT HIPSTEM

    MDR report key: 3001692 · Received March 8, 2013

    Report

    Report Number
    MW5029319
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LEFT HIP WAS IMPLANTED WITH A PINNACLE METAL-ON-METAL HIP ON (B)(6) 2002. SINCE THEN HAD CONTINUED AND INCREASING LEFT HIP PAIN, REQUIRING PAIN MEDICATION, INJECTIONS, AND THERAPY. INABILITY TO BE ACTIVE. DEVELOPED METALLOSIS AND COMPLEX FLUID COLLECTION AROUND HIP. REVISION WAS DONE (B)(6) 2013, AND NOW HAS ONGOING RECUPERATION PROBLEMS, USING WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98685 SUMMIT HIPSTEM HIP STEM KWA DEPUY ORTHOPAEDICS, INC. WH8PF 1001
    98686 ARTICAL/EZEM FEMORAL HEAD FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. YGL-91
    98707 DEPUY PINNACLE ACETABULAR CUP SYSTEM WITH METAL INSERT PINNACLE METAL-ON METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC. W1WGS1002
    98708 ULTRAMET MTL INSERT NEUTRAL NEUTRAL INSERT KWS DEPUY ORTHOPAEDICS, INC. YHU-75

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R