BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE DOUBLE HIGH TIBIAL INSERT

    MDR report key: 1335499 · Received March 5, 2009

    Report

    Report Number
    MW5010208
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    January 29, 2009
    Report Date
    February 27, 2009
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2007, HAD LEFT KNEE TOTAL ARTHROPLASTY, WRIGHT MEDICAL DEVICE. IN 2008, IN FOR LEFT KNEE DISLOCATED POLY INSERT, REPLACEMENT WAS WRIGHT MEDICAL. IN EARLY 2009, IN FOR LEFT KNEE DISLOCATED POLY INSERT, REVISION ARTHROPLASTY USING EXACTEC. DATES OF USE: 2007 TO 2009. DIAGNOSIS: LEFT KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE DOUBLE HIGH TIBIAL INSERT NONE HSH WRIGHT MEDICAL 116389303
    2 SIZE 2 LEFT, THICKNESS 17 MM NONE HSH WRIGHT MEDICAL 087462132

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R