BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3080888 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-16135
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    December 23, 2010
    Report Date
    October 10, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    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

    EXAMINATION OF REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. FURTHER INFORMATION REGARDING THIS REPORT WAS NOT MADE AVAILABLE TO CUSTOMER QUALITY. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FOUND ONE OTHER REPORT AGAINST THE 2290677 LOT CODE. NO REASON FOR REVISION WAS PROVIDED AND IT CANNOT BE DETERMINED IF THEY ARE SIMILAR IN NATURE. TWO OTHER REPORTS WERE FOUND AGAINST THE 2292347 LOT CODE FOR ALVAL AND PAIN. PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER REPORTS WERE FOUND AGAINST THE REMAINING LOT/PRODUCT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. AS THE CASE IS IN LITIGATION, FOLLOW UP FOR THIS ADDITIONAL INFORMATION WILL BE PERFORMED BY DEPUY LEGAL. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT SUFFERING FROM PAIN AND DISCOMFORT. ASPIRATION INDICATED METAL REACTION WHICH LED TO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183083 PINNACLE MTL INS NEUT36IDX52OD ACETABULAR LINER KWA 8010379 DEPUY INTL., LTD. 2292347

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention