BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3001775 · Received March 13, 2013

    Report

    Report Number
    1818910-2013-13736
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    September 7, 2012
    Report Date
    February 13, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. OPERATIVE NOTES RECEIVED FROM LEGAL. OPERATIVE NOTES INDICATE THAT THE PATIENT SUFFERED FROM A DISLOCATION. DOI: (B)(6) 2010- DOR: (B)(6) 2012 (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 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

    ADDITIONAL NARRATIVE: ADDITIONAL INFO: UPDATE REC'D 4/1/2013- PPD RECEIVED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.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

    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.

    Description of Event or Problem · 1

    OPERATIVE NOTES RECEIVED FROM LEGAL. OPERATIVE NOTES INDICATE THAT THE PATIENT SUFFERED FROM A DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105340 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTL., LTD. ¿ REG. # 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention