BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+5

    MDR report key: 2990223 · Received March 5, 2013

    Report

    Report Number
    1818910-2013-13213
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 22, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    (B)(4). NO DEVICE(S) ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER WI-3430. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93536 12/14 ARTICUL 40MM M SPEC+5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2465665

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other