BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 3893866 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21927
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 30, 2014
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. THE DEVICES ASSOCIATED WITH THIS REPORTING WERE RETURNED WITH A GREAT DEAL OF PATIENT BODILY FLUID AND MATTER ATTACHED ON ALL SURFACES. MEANINGFUL VISUAL EXAMINATION CANNOT BE PERFORMED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PRODUCT/LOT CODE COMBINATIONS FINDS NO OTHER REPORTS. THE SEARCH WAS NOT POSSIBLE AGAINST THE SCREWS AS THE NECESSARY PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371131 PINNACLE MTL INS NEUT40IDX56OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTL., LTD. ¿ REG. # 8010379 2434102

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention