BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 2.5 15.0

    MDR report key: 2990866 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13218
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED ANTICIPATED WEAR FOR A POLYETHYLENE KNEE DEVICE IMPLANTED FOR APPROXIMATELY THREE YEARS. THE INVESTIGATION DID NOT FIND ANY EVIDENCE OF PRODUCT FAILURE OR PRODUCT CONTRIBUTING TO THE REPORTED PATIENT INFECTION. BASED ON THE INVESTIGATION DETERMINATION OF NO PRODUCT FAILURE OF PRODUCT CONTRIBUTION TO THE REPORTED EVENT, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. POLY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95936 PFC SIGMARP STB TB IN 2.5 15.0 TIBIAL KNEE INSERT NJL 9616671 DEPUY (IRELAND) 3003449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention