BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    MDR report key: 1810500 · Received August 20, 2010

    Report

    Report Number
    1043534-2010-00340
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K972626
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00339.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED, DURING THE REVISION OF ANOTHER COMPONENT.

    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
    1 ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. 049846699

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R