BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3924958 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23080
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT CHROMIUM LEVELS. DOI: UNKNOWN, DOR: (B)(6) 2014 (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS IS NO LONGER REQUIRED. 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

    UPDATE REC'D 1/18/2016 - LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED COMPLICATIONS, INCLUDING, BUT NOT LIMITED TO PAIN, DISCOMFORT, DIFFICULTY AMBULATING, AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE 5/11/16- DISC 326 PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED EXTREME PAIN, DISFIGUREMENT FROM RESULTANT SURGERIES, AND PERMANENT DAMAGE TO MY HIP AREA DUE TO THE DEVICE AND REQUIRED INTERVENTIONAL CARE, PARTIAL OR COMPLETE LOSS OF MOBILITY, LOSS OF RANGE OF MOTION, AND MENTAL ANGUISH. MEDICAL RECORDS REPORTED A POSITIVE MARS MRI AND ELEVATED METAL IONS. REVISION SURGICAL REPORT NOTED METALLOSIS, METALLOSIS CYST, AND SMALL PSEUDOTUMOR. PATHOLOGY RESULT REPORTS NOTED SYNOVIAL HYPERPLASIA WITH NECROSIS, ALVAL, AND CHRONIC INFLAMMATION. STEM BEING ADDED FOR ALLEGED ELEVATED METAL IONS WITHOUT LAB RESULTS. THE COMPLAINT WAS UPDATED ON: JUN 2, 2016.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT CHROMIUM LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404520 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 3041438

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention