BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 2241406 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17753
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    November 1, 2010
    Report Date
    August 12, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    JDI
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE 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

    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 THE FOLLOWING: FOLLOWING IMPLANTATION, PATIENT BEGAN EXPERIENCING DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF HIS HIP IMPLANT, WHICH IN TURN NEGATIVELY AFFECTED HIS ABILITY TO WALK AND MOVE. FOLLOWING HIS IMPLANTATION, PATIENT BEGAN TO EXPERIENCE AUDIBLE NOISE EMANATING FROM HIS DEFECTIVE DEVICE. ON INFORMATION AND BELIEF, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSE TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT UNDERWENT REVISION SURGERY ON OR ABOUT (B)(6) 2010. EVALUATION OF THE ACETABULAR COMPONENT DURING THE REVISION SURGERY DID NOT DEMONSTRATE ANY SIGNS OF INGROWTH. CYSTIC FLUID, METAL DEBRIS, AND BOTH AN ANTERIOR AND POSTERIOR CYST WERE DISCOVERED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM M HEAD 36MM +3 TOTAL HIP REPLACEMENT JDI DEPUY WARSAW 1867677

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention