BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3010349 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-04273
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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

    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

    LITIGATION PAPERS ALLEGE: PATIENT IS A SURGICAL RECIPIENT OF A DEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT SYSTEM. CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BODY. PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT AND INFLAMMATION IN THE AREA OF THE IMPLANT. PATIENT ALSO EXPERIENCED DISLOCATION, DISARTICULATION, AND/OR A SLIPPING FEELING IN THE HIP JOINT AND A SENSATION THAT IMPLANT COULD NOT SUPPORT THEIR WEIGHT. PATIENT IS PART OF A MULTI-PLAINTIFF LITIGATION. IT IS UNCLEAR WHICH SYMPTOMS ARE SPECIFIC TO THE PATIENT AND WHETHER OR NOT PATIENT HAS BEEN REVISED. UPDATE: 2/20/2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. PATIENT WAS REVISED BECAUSE OF FAILURE OF INGROWTH OF THE ACETABULAR SHELL. ON (B)(6) /2007 THE PATIENT WAS IMPLANTED WITH METAL-ON-METAL AND NO REVISION WAS NOTED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113546 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD JDI 8010379 DEPUY INTL., LTD 2456652

    Patients

    Seq Age Sex Outcome Treatment
    1 Other