BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 4 10MM

    MDR report key: 2020025 · Received March 11, 2011

    Report

    Report Number
    1818910-2011-03997
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    POLY EXCHANGE AND WASHOUT FOR POSSIBLE INFECTION OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA STAB GVF INS 4 10MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA Z29D54

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention