BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2071549 · Received April 18, 2011

    Report

    Report Number
    2071549
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD STAGED BILATERAL HIP REPLACEMENT 2009 AT ANOTHER HEALTH CARE FACILITY WITH METAL ON METAL ARTICULATIONS AND VERTICAL CUP POSITION. PATIENT PRESENTED WITH BILATERAL HIP PAIN, RIGHT MORE SEVERE THAN LEFT. X-RAYS WERE SUSPICIOUS OF LOOSENING OF ACETABULAR COMPONENT RIGHT HIP, ELEVATED CHROMIUM, AND SERUM COBALT LEVELS. PREOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING OF ACETABULAR COMPONENT AND PROBABLE METAL-ON-METAL REACTION.====================== MANUFACTURER RESPONSE FOR DEPUY ACETABULAR CUP COMPONENT AND FEMORAL HEAD COMPONENT, UNKNOWN======================LOCAL DEPUY REPRESENTATIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, HIP KWA DEPUY FEMORAL HEAD DP99980246 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR