BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB LMRL S3 7MM

    MDR report key: 3941106 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23664
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2009
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO TKA TO ADDRESS LOOSENING OF THE TIBIAL TRAY 10 MONTHS AFTER UKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419964 PRSVN ALLPOLY TIB LMRL S3 7MM KNEE TIBIAL BEARING/INSERT HRY DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention