BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M 28MM 5

    MDR report key: 2892452 · Received January 2, 2013

    Report

    Report Number
    1818910-2013-00570
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    October 16, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. 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 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: SEVERE PAIN AND DISCOMFORT IN HER HIP AND LOWER BACK, WEAKNESS, MUSCLE CRAMPS, AND DIFFICULTY CONDUCTING ACTIVITIES OF DAILY LIVING **UPDATE** (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL. IMPLANT DATE FOR THE RIGHT HIP REPLACEMENT WAS CORRECTED AND PART/LOT IDENTIFIED WITH INVOICE SEARCH. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842 ARTICULEZE M 28MM 5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 1889607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other