BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA HIP IMPLANT

    MDR report key: 3964791 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24359
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 29, 2010
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 COMPLAINT STATES THAT ON (B)(6) 2002 THE PATIENT UNDERWENT AN ARTHROPLASTY FOR THE RIGHT HIP. FOLLOWING PAIN AND DIFFICULTY IN WALKING REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. NO MEDICAL RECORDS WERE RECEIVED TO CONFIRM THIS. NOTIFICATION WAS RECEIVED STATING THAT NO FURTHER INFORMATION OR RETURN OF PRODUCT IS AVAILABLE. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT OR PRODUCT NUMBERS WERE RECEIVED. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER SEP 419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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

    (B)(4). THE (B)(6) 2002 THE PATIENT WAS SUBJECTED TO AN INTERVENTION OF ARTHROPLASTY FOR THE RIGHT HIP. IN THIS OCCASION AN (UNKNOWN) OMEGA IMPLANT WAS IMPLANTED. FOLLOWING THIS INTERVENTION THE PATIENT STARTED TO FEEL PAIN AND DIFFICULTY IN WALKING. THE (B)(6) 2010 THE PATIENT WAS SUBJECTED TO A REVISION SURGERY WITH SUBSTITUTION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441718 OMEGA HIP IMPLANT HIP OTHER IMPLANT KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other