BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II COCR TIBIAL BASE

    MDR report key: 1934731 · Received December 21, 2010

    Report

    Report Number
    1043534-2010-00612
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    May 1, 2008
    Report Date
    November 18, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLIANT WAS STATED AGAINST THIS COMPONENT. THE PATIENT AND USER FACILITY INFORMATION WERE NOT PROVIDED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00610, 00611, 00613. THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY PER (B)(6), THE COMPONENT WAS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II COCR TIBIAL BASE KNEE COMPONENT HRY WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R