BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) ALL-POLY SINGLE POST ONLAY PATELLA

    MDR report key: 2942242 · Received February 4, 2013

    Report

    Report Number
    1043534-2013-00191
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    July 18, 2011
    Report Date
    October 22, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00188, 00189, 00190. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORT IT WAS DETERMINED THAT THIS WAS REPORTED IN ERROR. PLEASE VOID THE INITIAL AND FOLLOW UP REPORTS. PRODUCT WAS NOT REVISED AND NO COMPLAINT STATED AGAINST THE PRODUCT.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46488 ADVANCE(R) ALL-POLY SINGLE POST ONLAY PATELLA KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 124157701

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention