BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 58MM

    MDR report key: 3113389 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17100
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 19, 2013
    Report Date
    October 2, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ ((B)(4)) COMPLAINT (B)(4). REASON FOR ORIGINAL COMPLAINT. MAUDE EVER REPORT ((B)(4)) STATES: DEPUY HIP PINNACLE IMPLANT WITH ARTICULEZE FEMORAL HEAD, PINNACLE SECTOR II ACETABULAR CUP WITH ALTRX LINER. SUMMIT TAPERED HIP STEM WITH PROCOAT. THIS LINED WITH PINNACLE PROCOAT (POLYETHYLENE) ACETABULAR CUP WORKED FOR 7 MONTHS AFTER SURGERY. THEN THE DEPUY IMPLANT HAS CAUSED EXTREME PAIN IN INNER THIGH AND HIP AREA EXTENDING BELOW THE KNEE. PAIN ALWAYS PRESENT, BUT WORSE WHEN ATTEMPTING TO GET UP FROM THE SITTING POSITION. PAIN EXCEED PAIN PRIOR TO SURGERY. SURGEON USED DEPUY IMPLANT AFTER BEING TOLD CLEARLY NOT TO USE ANY DEPUY PRODUCT BECAUSE OF ALL THE TV ADS VIEWED FOR THREE MONTHS PRIOR TO SURGERY. SURGEON STATED THAT THE BONE GROWTH AROUND FEMUR "LOOKED STRANGE AND CLOUDY," HIS INITIAL TESTS WERE UNEVENTFUL, BUT PAIN CONTINUES. HIP GETTING WORSE. HAVING CLICKING SOUNDS COMING FROM HIP AND THE IMPLANT FEELS LOOSE, LIKE IT IS GETTING WORSE WITH TIME. DOI: (B)(4) 2010 - DOR: NONE REPORTED *** UPDATE - PATIENT WAS REVISED (B)(6) 2012 TO ADDRESS DISLOCATION. *** **UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT AND COMPONENT LOOSENING. THE MDR DECISION IS BEING REVERSED FOR THE ACETABULAR CUP AND FEMORAL STEM TO ADDRESS LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214068 PINNACLE SECTOR II CUP 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS INC US EG2EP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention