BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 4071458 · Received September 9, 2014

    Report

    Report Number
    1818910-2014-27543
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). THIS 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

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. UPON REVISION METALLOSIS WAS NOTED. DOI: 2008 - DOR: (B)(6) 2014 (RIGHT HIP). 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. UPON REVISION METALLOSIS WAS NOTED.

    Description of Event or Problem · 1

    UPDATE 3/14/2016: LITIGATION RECEIVED. LITIGATION ALSO ALLEGES DISCOMFORT. A DOI WAS PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 3/18/2016.

    Description of Event or Problem · 1

    UPDATE 5/3/16- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED HIP DISCOMFORT IN (B)(6) 2012, SEVERE FATIGUE IN 2012, ANXIETY IN 2013, HEADACHES/TREMORS/NEUROLOGICAL IMPAIRMENTS IN (B)(6) 2013, TEETH CHATTERING/HEAD TREMORS IN (B)(6) 2014, MIGRAINES IN (B)(6) 2014, PSEUDOTUMOR, OVARIAN CYSTS IN (B)(6) 2013 AND LOW BLOOD PRESSURE IN 2013 TO PRESENT. MEDICAL RECORDS REPORTED JOINT SWELLING, CYSTS/GROWTHS, TWITCHING OF HEAD/NECK, HEADACHES, GROIN PAIN, RIGHT HIP SQUEAKING, FINGER NUMBNESS AND LEFT LEG LONGER THAN RIGHT. LAB RESULT REPORTS FOR METAL IONS GREATER THAN 7 PARTS PER BILLION. PRIMARY SURGICAL REPORT NOTED THAT WHILE IMPACTING THE FEMORAL STEM THERE WAS A VERY SMALL FRACTURE LINE IN CALCAR REGION THAT WAS REPAIRED WITH CABLE. REVISION SURGICAL REPORT NOTED PAIN, METAL TOXICITY, METALLOSIS, TRUNNIONOSIS, OSTEOLYSIS AND CUP IN EXCESSIVE ANTEVERSION BUT NOT REVISED AT THIS TIME. PATHOLOGY RESULT REPORT NOTED PSEUDOTUMOR. FEMORAL STEM AND CUP ADDED TO COMPLAINT. THE COMPLAINT WAS UPDATED ON: MAY 25, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553784 PINNACLE MTL INS NEUT36IDX50OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 2744037

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention