BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 1850527 · Received October 1, 2010

    Report

    Report Number
    1043534-2010-00396
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 20, 2010
    Report Date
    April 1, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K974328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00395. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 1043534-2010-00406, NOT 1043534-2010-00395 AS ORIGINALLY REPORTED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS REVISED DUE TO LOOSENESS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY INSERTING THE TIP OF THE EZ-28 INJECTOR INTO THE INCISION. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE AND SUTURE THE INCISION. THE PT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT HIP COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. 04345132

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R