BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3341767 · Received September 11, 2013

    Report

    Report Number
    1818910-2013-27021
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    September 12, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K120599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2012, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED.PATIENT RESIDENCE: MI.

    Description of Event or Problem · 1

    PFS AND PPF RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PFS ALLEGES PAIN, STIFF, SORE AND LIMITED MOBILITY. PPF ALLEGES ELEVATED METAL IONS.

    Description of Event or Problem · 1

    PPF ALLEGE ELEVATED METAL IONS. PPF ALLEGATION WAS ALREADY REPORTED. THE METAL POISONING IN PATIENT HARM WAS CHANGE TO BLOOD HEAVY METAL INCREASED AND ADDED PATIENT NAME IN ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455424 S-ROM M HEAD 36MM +3 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2396644

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other