BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+1.5

    MDR report key: 2879636 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-29207
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE OTHER REPORTED INCIDENT AGAINST LOT 2842431 AND OTHER REPORTED INCIDENTS AGAINST LOT 2868410 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR 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 PATIENT HAS BEEN CAUSED TO SUSTAIN SERIOUS INJURIES; HAS SUFFERED AND WILL CONTINUE TO SUFFER GREAT PAIN OF BODY AND MIND; HAS BEEN AND WILL IN THE FUTURE BE DEPRIVED OF EARNINGS AND EARNING CAPACITY; HAS SUSTAINED PERMANENT DISABILITY AND DEFORMITY; HAS BEEN CAUSED GREAT INCONVENIENCE, AND HAS INCURRED AND WILL IN THE FUTURE INCUR HOSPITAL, DOCTORS AND/OR RELATED EXPENSES IN AN EFFORT TO TREAT AND/OR BE CURED OF SAID INJURIES. **UPDATE**(B)(4) 2012 - MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATE PART/LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+1.5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 2868410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other