BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3132167 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17682
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 26, 2014
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS FINDS NO OTHER REPORTS. THE SEARCH AGAINST THE UNKNOWN DEVICES WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATIONS WAS NOT PROVIDED. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE RECEIVED 5/19/14. THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE RIGHT HIP. PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED ION LEVELS AND METALLOSIS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, TISSUE DAMAGE AND TOXIC LEVELS OF COBALT AND CHROMIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236919 PINNACLE MTL INS NEUT36IDX54OD TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. ¿ REG. # 8010379 1914175

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other