BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2112807 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08790
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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 THAT ON OR ABOUT (B)(6) 2009, PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON HIS RIGHT SIDE. SOMETIME AFTER, PATIENT ALLEGEDLY EXPERIENCED MEDICAL COMPLICATIONS.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND DOR. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THE FEMORAL HEAD IS NOW BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ACETABULAR CUP TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention