BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3170709 · Received June 14, 2013

    Report

    Report Number
    1818910-2013-18937
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 11, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    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 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.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIGH COCR LEVELS AND METALOSIS. OSTEOLYSIS WAS ALSO REPORTED.

    Description of Event or Problem · 1

    UPDATE APR 10, 2018: PFS AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATIONS ADDED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND METALLOSIS. REVISION NOTE STATED, THE HIP WAS ASPIRATED AND 10 ML OF YELLOW PARTICULATE FLUID WAS REMOVED. A RADICAL CAPSULECTOMY AND SYNOVECTOMY WAS DONE WITH THIS TISSUE SHOWING MARKED FOREIGN BODY SYNOVITIS. THE FEMORAL BALL WAS REMOVED AND SHOWED LITTLE CORROSION OF THE TRUNNION. THERE WAS A HEMOLYTIC REACTION AND COAGULATION REACTION ON THE BACKSIDE OF THE INNER AND FRONT SIDE OF THE SOCKET. THERE WAS OSTEOLYSIS UNDERNEATH THE COLLAR.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIGH COCR LEVELS AND METALLOSIS. OSTEOLYSIS WAS ALSO REPORTED. UPDATE 07/11/2013 - CLINICAL REPORT WAS RECEIVED. CLINICAL REPORT INDICATES THE PATIENT WAS ALSO REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION. UPDATING LOT INFORMATION FOR THE ACETABULAR SHELL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271889 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA 8010379 DEPUY INTL., LTD. 2462090

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention