BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX56OD

    MDR report key: 3032744 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-14817
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE INSERT PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. A PREVIOUS REVIEW OF THE FEMORAL HEAD DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE INSERT PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. A PREVIOUS REVIEW OF THE FEMORAL HEAD DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DIFFICULTY AMBULATING, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    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

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

    UDI: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN.

    Description of Event or Problem · 1

    UPDATE REC'D 10/10/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTE REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, BUT THERE WAS NO MENTION OF INCREASED METAL IONS AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136765 PINNACLE MTL INS NEUT36IDX56OD INSERT KWA DEPUY ORTHOPAEDICS INC US 1094767

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention