BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 3890189 · Received June 24, 2014

    Report

    Report Number
    1818910-2014-21780
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. DOI: (B)(6) 2010 - DOR: (B)(6) 2014 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 3163413 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED COMPLAINTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING REVISION INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE. 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 STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

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

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH ON THE LINER FOUND ADDITIONAL REPORTS HOWEVER, PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED. 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 PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

    Description of Event or Problem · 1

    PT. WAS HAVING PAIN AND HE HAD A METAL ON METAL LINER IN WHICH WAS A 56 AND AN 40-3 HEAD. TOOK LINER AND HEAD OUT WHILE PULLING POLY LINER IN. RIGHT HIP. LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

    Description of Event or Problem · 1

    UPDATE 9/30/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED METALLOSIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE STEM IS BEING ADDED TO THE COMPLAINT.THE COMPLAINT WAS UPDATED ON:10/26/2015.

    Description of Event or Problem · 1

    PINNACLE PPF RECEIVED. PPF WAS REVIEWED FOR MDR REPORTABILITY. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF REPORTED OF DISLOCATION.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR. DOI: (B)(6) 2010 - DOR: (B)(6) 2014 (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367724 PINNACLE MTL INS NEUT40IDX56OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 3163413

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention