BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2807417 · Received October 29, 2012

    Report

    Report Number
    1818910-2012-27151
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 22, 2012
    Report Date
    June 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE 1886626. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2023665 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2013 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM DISCOMFORT, INFLAMMATION, AND A POPPING/SNAPPING SENSATION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS ONE OTHER REPORTED INCIDENT AGAINST THE PINNACLE MTL INSS PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE ARTICULEZE M HEADS PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOUND ONE MANUFACTURING DEVIATION, NUMBER 352 AT OPERATION NUMBER 5 ISSUE MATERIAL, RAISED REGARDING REVISION TO RAW MATERIAL ISSUING PROCEDURE. THIS WAS CONFIRMED THAT THE DEVIATION SHOULD HAVE HAD NO EFFECT ON THE REPORTED INCIDENT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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

    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 MALALIGNMENT OF THE METAL LINER, ELEVATED LABS, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 1886626

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention