BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 2.5 15MM

    MDR report key: 1063273 · Received June 18, 2008

    Report

    Report Number
    1818910-2008-02425
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    DEPUY-ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT/PACKAGING AND REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE SIZE 3 PRODUCT WAS LABELED AS SIZE 2. THE ROOT CAUSE IS ATTRIBUTED TO HUMAN ERROR IN THE LABEL PROCESS. DEPUY CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF THIGH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA STAB GVF INS 2.5 15MM 87JWH JWH DEPUY-ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA Z55LC4000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention