BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 28MM +6 M HEAD

    MDR report key: 2922800 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-00851
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2012 - PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL 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 AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFFS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PLAINTIFF HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS RIGHT THIGH AND GROIN. HE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIS HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE - (B)(4) 2012- PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATED PATIENT IS BILATERAL. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27644 SROM 28MM +6 M HEAD FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910  YCY22

    Patients

    Seq Age Sex Outcome Treatment
    1 Other