BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML HIGH OFFSET LG STAT 15.0MM

    MDR report key: 2922860 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-02124
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    October 28, 2009
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGAION.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES YC3FB1, 1092398, AND XR9DA1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE 1158115 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2006, BILATERAL PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP IMPLANT ON HIS RIGHT SIDE (LEFT SIDE WAS ENTERED IN A SEPARATE COMPLAINT). FOLLOWING THE SURGERY, PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT, AND MECHANICAL LOOSENING AND COMPLICATIONS OF HIS RIGHT TOTAL HIP ARTHROPLASTY. ON (B)(6) 2009, PATIENT WAS REVISED ON HIS RIGHT SIDE. UPDATE - PLAINTIFF FACT SHEET WAS RECEIVED. THE XXX WAS UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27439 AML HIGH OFFSET LG STAT 15.0MM AML IMPLANT : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US Y91C61000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention