BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ4

    MDR report key: 6109065 · Received November 17, 2016

    Report

    Report Number
    1818910-2016-31640
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 PAIN AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759634 MBT CEM KEEL TIB TRAY SZ4 KNEE TIBIAL TRAY NJL DEPUY IRELAND 9616671 3011987

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention