BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX62OD

    MDR report key: 3190321 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19888
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    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.

    Additional Manufacturer Narrative · 1

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

    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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. MEDICAL RECORDS WERE 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 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. MEDICAL RECORDS WERE 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 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

    UPDATE REC¿D 5/7/2014¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDIAL RECORDS IT WAS CONFIRMED THAT THERE WAS NO MENTION OF METALLOSIS. THE INVESTIGATION IS ONGOING. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. MEDICAL RECORDS AND X-RAYS WERE RECEIVED AND REVIEWED. 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 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. THERE WAS NO SIGN OF METALLOSIS, AND THE SURGEON SAID THERE WAS VERY LITTLE WEAR ON THE PARTS REMOVED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. THERE WAS NO SIGN OF METALLOSIS, AND THE SURGEON SAID THERE WAS VERY LITTLE WEAR ON THE PARTS REMOVED. UPDATE (B)(4) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT HAD INCREASED METAL ION LEVELS, METAL DEBRIS, AND FLUID CONSISTENT WITH METALLOSIS. NOTED UPON REVISION WAS A CYST IN THE HIP JOINT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATE: LITIGATION PAPERS RECEIVED (B)(4) 2014. LITIGATION ALLEGES DISCOMFORT AND INFLAMMATION. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290779 PINNACLE MTL INS NEUT44IDX62OD ACETABULAR METAL KWA DEPUY ORTHOPAEDICS, INC. 1818910 2906841

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention