BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +12

    MDR report key: 3423452 · Received October 22, 2013

    Report

    Report Number
    1818910-2013-31188
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    December 9, 2011
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE XVP79 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 1973254 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES: IN 2002, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM IMPLANT IN HER RIGHT HIP. PATIENT SUFFERED DEBILITATING PAIN, SWELLING, INFLAMMATION, INFECTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. IN (B)(6) 2005, PATIENT WAS REVISED AND IMPLANTED WITH A NEW PINNACLE MOM DEVICE. IN 2010, THE NEW IMPLANT BEGAN SLIPPING OUT OF THE SOCKET CAUSING INTENSE PAIN, DISCOMFORT, AND THE INABILITY TO WALK WITHOUT ASSISTANCE. PATIENT IS UNABLE TO BE REVISED A SECOND TIME DUE TO TOO LITTLE BONE STRUCTURE REMAINING. DOI: 2002 - DOR: (B)(6) 2005 (RIGHT HIP; FIRST IMPLANTATION); DOI: (B)(6) 2005 - DOR: NONE (RIGHT HIP; SECOND IMPLANTATION). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ORIGINALLY IMPLANTED (B)(6) 2002, REVISED (B)(6) 2005 BECAUSE OF INSTABILITY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    THE PATIENT HARM AND PATIENT NAME WERE UPDATED AND ADDED PRODUCT EXPERIENCE CODE AND LAWYER. STEM, CUP, FIVE SCREWS AND THE UNKNOWN HIP IMPLANT WERE ADDED TO THE IMPACTED PRODUCT DUE TO THE "ALLEGES" LOOSENING, INFECTION AND FRACTURED COMPONENT FROM THE PPF. THE FIRST REVISION WAS CAPTURED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540979 ARTICULEZE M HEAD 36MM +12 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1888132

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other