BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANCE SZ 2 STD OFFSET

    MDR report key: 2925812 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-01402
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 29, 2012
    Report Date
    December 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K942370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1846928, YK8F81000, AND Y27JN1000.A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1850407 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND CHRONIC DISLOCATIONS. UPDATE: (B)(6) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. IT WAS NOTED THAT THE PATIENT HAD SEVERAL CLOSED REDUCTIONS BECAUSE OF DISLOCATION ISSUES. DURING THE REVISION IT WAS NOTED THAT THE STEM WAS GROSSLY LOOSE. THE SHELL WAS NOTED TO BE RETROVERTED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29453 ENDURANCE SZ 2 STD OFFSET MISCELLANEOUS HIP STEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US YK8F81000

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention