BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 3 12.5MM

    MDR report key: 3013496 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-04282
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    October 17, 2008
    Report Date
    March 11, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE NEWLY PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. NOT RETURNED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE:PATIENT WAS REVISED DUE TO INFECTION. **UPDATE** 3/11/2013- ADDITIONAL INFORMATION RECEIVED FROM LEGAL. IN ADDITION TO INFECTION, PATIENT SUFFERED A FRACTURE OF THE MEDIAL FEMORAL CONDYLE OF THE DISTAL FEMUR. ALL PRODUCTS HAVE BEEN ADDED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115239 SIGMA STAB GVF INS 3 12.5MM TIBIAL INSERT JWH DEPUY RAYNHAM B81J74000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention