BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 2870282 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-83558
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED: DATE OF BIRTH, EXPIRATION DATE AND UDI, 510K, AND PATIENT AND DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT, SWELLING IN THE LEG, AND DIFFICULTY SLEEPING. UPDATE: 12/27/2012 - IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2012 TO ADDRESS CHRONIC INFLAMMATION AND OSTEOLYSIS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT, SWELLING IN THE LEG, AND DIFFICULTY SLEEPING.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX56OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2842826

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other