BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 28MM +0

    MDR report key: 2963583 · Received February 15, 2013

    Report

    Report Number
    1818910-2013-12461
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    PMA / PMN Number
    K011533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DISABILITY. DOI: (B)(6) 2006 - DOR: NONE REPORTED (LEFT HIP). UPDATE (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. THE STICKER SHEET INDICATED THAT THE PATIENT WAS IMPLANTED WITH POLY. DUE TO ALLEGATIONS OF PAIN, ALL PRODUCTS ARE BEING REPORTED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. PROVIDED PATIENT RECORDS HAVE BEEN REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE THE COMPLAINT IS NOT PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DISABILITY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DISABILITY. **UPDATE** (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. THE STICKER SHEET INDICATED THAT THE PATIENT WAS IMPLANTED WITH POLY. DUE TO ALLEGATIONS OF PAIN, ALL PRODUCTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68852 DELTA CER HEAD 11/13 28MM +0 FEMORAL HEAD LZO DEPUY ORTHOPAEDICS INC US 1912588

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other