BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2900860 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-10563
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    JDI
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH 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 IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, AND TOXIC COBALT CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8816 PINNACLE MTL INS NEUT36IDX52OD METAL LINER JDI DEPUY ORTHOPAEDICS, INC. 1818910  1888377

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other