BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUFLEX PIP IMPLANT SZ 2

    MDR report key: 1618441 · Received February 26, 2010

    Report

    Report Number
    1818910-2010-00641
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 27, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    K001922
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    PT COMPLAINED OF FINGER JOINT PAIN. DURING REVISION SURGERY, SURGEON DISCOVERED THAT THE ORIGINAL PIP FINGER JOINT HAD BROKEN IN THE MIDDLE AND SEPARATED INTO TWO STEM ENDS, BOTH STILL IN PLACE WITHIN THE BONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUFLEX PIP IMPLANT SZ 2 87KYJ KYJ DEPUY ORTHOPAEDICS, INC. NA AY3F51000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention