BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX ROT PLAT TIB PLAT LG+

    MDR report key: 2945493 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-11951
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE REPORTED LOOSENING. 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 ROOT CAUSE OF THE LOOSENING BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY PRODUCT ERROR AS A CONTRIBUTING FACTOR OR DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 SUBSIDENCE OF THE TIBIAL TRAY. THE TIBIAL TRAY WAS ALSO LOOSE AT THE CEMENT/BONE INTERFACE; HOWEVER, THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. OSTEOLYSIS AND POLY WEAR OF THE INSERT WERE ALSO REPORTED. IT WAS ALSO LEARNED THAT THE PATIENT WAS PREVIOUSLY REVISED ON (B)(6) 2000, TO ADDRESS LATERAL PATELLAR MALALIGNMENT (MEDICAL RECORDS SEEM TO INDICATE THIS WAS LIGAMENT-RELATED), AND LOOSENING OF THE TIBIAL TRAY. THE LOOSENING INTERFACE IS NOT INDICATED. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51167 LCS TEX ROT PLAT TIB PLAT LG+ TIBIAL KNEE PROSTHESIS NJL DEPUY ORTHOPAEDICS, INC. T3SEJ1012

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention