BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S4 10.0

    MDR report key: 2791985 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-23641
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    August 13, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    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 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2013 - PATIENT'S X-RAYS WERE RECEIVED. COMPLAINT WAS RE-OPENED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. RADIOGRAPHIC INFORMATION WAS MADE AVAILABLE FOR REVIEW. 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. UPDATE - (B)(4) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED (B)(4) 2013. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. REVISION OPERATIVE REPORT WAS OBTAINED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES: POLY GROSSLY WORN, MIGRATION OF TIBIAL COMPONENT INTO VARUS POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP CV TB/IN S4 10.0 TIBIAL INSERT NJL DEPUY IRELAND 2503088

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention