BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +12

    MDR report key: 2791948 · Received October 15, 2012

    Report

    Report Number
    1818910-2012-77130
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    September 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, MANUFACTURER NAME/ADDRESS, CATALOG #/LOT #, IMPLANT DATE, CONTACT OFFICE NAME/ADDRESS, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. PRODUCT WAS INITIALLY REPORTED ON (B)(4). 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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A 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 AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, DECREASED RANGE OF MOTION AND LOSS OF MUSCLE MASS AND DETERIORATION OF THE BONE AND SOFT TISSUE AS A RESULT OF THE IMPLANTED ASR HIP. IN ADDITION, THE ASR HIP ALLEGEDLY EXHIBIT AUDIBLE NOISES SUCH AS SQUEAKING AND POPPING SOUNDS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +12 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 1045789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other