BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUFLEX MCP IMPLANT SZ 30

    MDR report key: 6019970 · Received October 12, 2016

    Report

    Report Number
    1818910-2016-29191
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 24, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    K970544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    (B)(4). 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

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED FRACTURE THROUGH THE HINGED AREA. NO FRACTURE FEATURES COULD BE IDENTIFIED AND THEREFORE A CAUSE OF FAILURE COULD NOT BE DETERMINED. NO MATERIAL DEFECTS OR INCLUSIONS WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE FAILURE OF THE IMPLANTS. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE FRACTURED DEVICES AND 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

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    UPDATE REC'D 18 OCTOBER 2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, UPON REVISION SYNOVITIS WAS NOTED IN MCP-2. MCP2-5 WERE FOUND TO HAVE DESTRUCTION OF THE NEUFLEX PROSTHESIS AND MCP-5 WAS NOTED TO BE BROKEN. AT THIS TIME THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    PATIENT RECEIVED SEVERAL NEUFLEX PROTHESIS ON RIGHT HAND. ALL HAD TO BE REVISED BECAUSE OF FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674231 NEUFLEX MCP IMPLANT SZ 30 FINGER IMPLANT KYJ DEPUY ORTHOPAEDICS, INC. A25GX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention