BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) HIP

    MDR report key: 2484444 · Received March 8, 2012

    Report

    Report Number
    1043534-2012-00225
    Event Type
    Injury
    Date Received
    March 8, 2012
    Report Date
    March 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. THE REPORTER DID INDICATE THAT NO REVISION HAS OCCURRED TO DATE. NO PATIENT, CATALOG NUMBER, OR EVENT DATES HAVE BEEN ADVISED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME/CONSERVE(R) HIP; COMMON DEVICE NAME/PRODUCT CODE KWA. REPORTER ADVISES THE PATIENT HAS BEEN REVISED; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE PRODUCT WAS NOT RETURNED. THERE IS NOT ENOUGH INFORMATION AVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ALLEGEDLY THE ION PERCENTAGE MEASURED IN BLOOD WHERE HIP PROSTHESIS HAVE BEEN INSTALLED IS TOO HIGH. NO REVISION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) HIP HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R