BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3912495 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22640
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 20, 2012
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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 ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390464 S-ROM M HEAD 36MM +3 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 1981395

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention