BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+8.5

    MDR report key: 2770442 · Received October 3, 2012

    Report

    Report Number
    1818910-2012-21822
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    May 3, 2010
    Report Date
    September 7, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH 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 IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT METAL HEAD AND METAL LINER CAUSED LARGE AMOUNTS OF METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. ADDITIONALLY, PATIENT ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION.

    Description of Event or Problem · 1

    PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2591280

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other