BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ASR

    MDR report key: 2250872 · Received September 14, 2011

    Report

    Report Number
    2250872
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH DEPUY HIP REPLACEMENT IN (B)(6) 2007 NOW WITH PAIN AND SUGGESTED PROXIMAL FEMORAL BONE LOSS BY RADIOGRAPH. HIP COMPONENTS REPLACED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR DEPUY ASR ACETABULAR COMPONENT FEMORAL HEAD AND TAPER ADAPTO KWA DEPUY ORTHOPAEDICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR