BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA TIB TRAY CEM SZ3

    MDR report key: 2774325 · Received October 5, 2012

    Report

    Report Number
    1818910-2012-23210
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K882234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    THIS IS A DUPLICATE REPORT OF 1818910-2012-83053. THIS REPORT, 1818910-2012-23210, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2012-283053. ALSO, ATTACHED TO THE REPORT, IS UF REPORT#06-0010-2012-0007.

    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

    UPDATE: CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED (B)(6) 2012 FOR ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. UPDATE - (B)(4) 2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE AN OSTEOLYTIC DEFECT ON THE PATIENTS FEMORAL COMPONENT. THE PATELLA WAS ALSO FOUND TO BE LOOSE AT REVISION. THE FEMORAL COMPONENT WAS ADDED TO THE COMPLAINT AND THE PATELLA WAS REOPENED. UPDATE - (B)(4) 2013 - X-RAYS WERE RECEIVED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER PREVIOUSLY REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. RADIOGRAPHIC INFORMATION WAS 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 ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES: MIGRATION/LOOSENING - TIBIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA TIB TRAY CEM SZ3 TIBIAL TRAY JWH DEPUY RAYNHAM 915694

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention