BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 2983548 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12966
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    June 20, 2012
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY WALKING. IT IS ALSO ALLEGED THAT THE PATIENT WAS REVISED TO ADDRESS A NONUNION SITE OF THE RIGHT FEMUR.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY WALKING. IT IS ALSO ALLEGED THAT THE PATIENT WAS REVISED TO ADDRESS A NONUNION SITE OF THE RIGHT FEMUR. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT, SORENESS, DIFFICULTY WITH DAILY LIVING ACTIVITIES, AND TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD, TISSUE, AND BONE. PART AND LOT INFORMATION HAS BEEN IDENTIFIED THROUGH AN INVOICE SEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86201 PINNACLE MTL INS NEUT40IDX56OD METAL LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2610600

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention