BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2895192 · Received January 3, 2013

    Report

    Report Number
    1818910-2013-10181
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 7, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM FRICTION WEAR BETWEEN THE COBALT CHROMIUM METAL HEAD AND COBALT CHROMIUM METAL LINER, WHICH HAS CAUSED SEVERE PAIN, DISCOMFORT, AND TROUBLE WALKING. UPDATE - (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED FROM LEGAL. PART/LOT PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM FRICTION WEAR BETWEEN THE COBALT CHROMIUM METAL HEAD AND COBALT CHROMIUM METAL LINER, WHICH HAS CAUSED SEVERE PAIN, DISCOMFORT, AND TROUBLE WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2994 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2117210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other