BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 2905613 · Received January 9, 2013

    Report

    Report Number
    1043534-2013-00032
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    August 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K031963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00033, 00034. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY IN (B)(6) 2011, THE PATIENT FELT A PAIN. THE SURGEON DOUBTED LOOSENING OF THE CUP AND/OR THE STEM. HE PERFORMED REVISION SURGERY ON (B)(6) 2012. NORMAL ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12288 CONSERVE(R) PLUS CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 039805752

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention