BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINK(R) PTG ENDO MODELL A ROTAT.

    MDR report key: 2087352 · Received May 12, 2011

    Report

    Report Number
    1043534-2011-00201
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 15, 2011
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4), LOT NO: 0705090129. DEVICE HISTORY RECORD REVIEWED. (B)(4) - EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED, UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). WRIGHT MEDICAL TECHNOLOGY, INC., IS REPORTING ON BEHALF OF THE MANUFACTURER, (B)(4). THE 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. A MEDWATCH 3500 WAS OBTAINED FROM THE USER FACILITY AND ATTACHED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) PTG ENDO MODELL A ROTAT. KNEE COMPONENT JDI WALDEMAR LINK GMBH & CO. KG 070509/0129

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR