BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIGMA 3POST RDDOME PAT 41MM

    MDR report key: 3241272 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21829
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 27, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. THE INITIAL REPORTING STATED RADIOGRAPHIC REVIEWS ARE NOT AVAILABLE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. 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 DEVICE AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE NEWLY PROVIDED INFORMATION. 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

    (B)(4). 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES: PATIENT WAS EXPERIENCING EXTENSOR MECHANISM INSUFFICIENCY; TORN CAPSULE AND QUAD TENDON. ALSO REPORTED A VASCULAR DVT; FEMORAL, POPLITEAL AND PERITONEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340649 PFCSIGMA 3POST RDDOME PAT 41MM PATELLA JWH JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. D12112501

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention