BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 2110656 · Received June 1, 2011

    Report

    Report Number
    1043534-2011-00246
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 28, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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 MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00245.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 039824496. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED. UNDETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 039824496

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R