BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HIP BALL 32MM +11

    MDR report key: 2922277 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-11168
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK880269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. PROVIDED PATIENT RECORDS HAVE BEEN REVIEWED. FROM A MEDICAL PERSPECTIVE, WITH THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THAT THE COMPLAINT IS 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28062 TOTAL HIP BALL 32MM +11 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. V84EE1042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention