BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M 28MM 1.5

    MDR report key: 2854604 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-83028
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    February 4, 2013
    Report Date
    January 14, 2020
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2012-83330. THIS REPORT, 1818910-2012-83028 WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW UP REPORT WILL HAS BEEN SUBMITTED TO REJECT 1818910-2012-83330.

    Additional Manufacturer Narrative · 1

    THE 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 DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, AND A CONSTANT LIMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M 28MM 1.5 FEMORAL HEAD JDI DEPUY INTL., LTD. 3012337

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other