BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 2 12.5

    MDR report key: 3063604 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15500
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). NO ADDITIONAL INFORMATION WAS OBTAINED. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE AND PAIN. POLY WEAR OF THE INSERT WAS ALSO REPORTED, AS WELL AS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE; HOWEVER, THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166100 PFC SIGMARP STB TB IN 2 12.5 TIBIAL KNEE INSERT NJL 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention