BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 1914278 · Received December 3, 2010

    Report

    Report Number
    1043534-2010-00499
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    September 4, 2009
    Report Date
    November 5, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THS 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. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. PRODUCT NOT RETURNED FOR EVALUATION. NO CONCLUSIONS CAN BE REACHED WITH THE INFORMATION PROVIDED; HOWEVER NO PRODUCT-RELATED ISSUES CAN BE ISOLATED REGARDING THIS EVENT. NO CORRECTIVE ACTION REQUIRED AS ANALYSIS SHOWS NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 097459530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R