BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUFLEX MCP IMPLANT SZ 40

    MDR report key: 2435964 · Received February 2, 2012

    Report

    Report Number
    1818910-2012-03024
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KYJ
    PMA / PMN Number
    K970544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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

    EXAMINATION OF THE RETURNED IMPLANT BY A DEPUY (B)(4) MATERIAL RESEARCH SCIENTIST CONFIRMED THE COMPLAINT; A FATIGUE CRACK INITIATED AT THE TOP RIGHT CORNER ON THE DORSAL SIDE OF THE FRACTURE ADJACENT TO THE HINGE BODY OF THE DISTAL STEM. A SECOND FATIGUE CRACK INITIATED NEAR THE CENTER ON THE PALMER SIDE OF THE FRACTURE. FATIGUE RESULTS FROM REPETITIVE LOADING AT LOADS EXCEEDING THE ENDURANCE LIMIT OF THE MATERIAL. FATIGUE INITIATION ON BOTH THE DORSAL AND PALMER SIDES WOULD INDICATE REVERSE LOADING WAS OCCURRING ON THE DISTAL STEM. AN ADDITIONAL LARGE CRACK WAS DETECTED ON THE DORSAL SIDE OF THE PROXIMAL STEM ADJACENT TO THE HINGE BODY. NO MATERIAL ANOMALIES WERE DETECTED AT THE CRACK INITIATION SITES. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS THE IMPLANT BREAKING AT THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUFLEX MCP IMPLANT SZ 40 FINGER JOINT PROTHESIS KYJ DEPUY WARSAW B4SG11

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention