BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ4

    MDR report key: 5818852 · Received July 25, 2016

    Report

    Report Number
    1818910-2016-23867
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    December 17, 2014
    Report Date
    July 18, 2016
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATIONS. 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 THE 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 CORRESPONDENCE: PATIENT REPORTS HAVING A KNOT ON THE SIDE OF HER KNEE, BLOOD CLOTS, SWELLING, AND IT FEELS UNSTABLE. UPDATE REC'D 10/8/2014 - PATIENT CALLED COMPLAINING OF HER KNEE POPPING AND CAUSING PAIN. SHE ALSO CLAIMS SHE FELL 3 TIMES BECAUSE IT QUIT WORKING. UPDATE REC'D 07/18/2016 MW 5063144 STATES PATIENT WAS REVISED (B)(6) 2014: I HAD A KNEE REPLACEMENT. I WAS TOLD I WOULDN'T HURT ANYMORE. THAT WASN'T TRUE. THE PAIN JUST GOT WORSE AND WORSE. MY KNEE WAS SWOLLEN AND IT HAD A KNOT ON THE SIDE OF MY KNEE. I WENT TO THE DR. AND HE SAID I HAD TO HAVE ANOTHER KNEE REPLACEMENT, THAT THE ONE I HAD WAS LOOSENING. THAT IF I DIDN'T , IT WOULD PUT ME ON THE GROUND. WELL , BEFORE I COULD HAVE IT DONE, I FELL 3 TIMES. TWICE I HAD TO GO TO THE HOSPITAL. I GOT THE REVISION AND I STILL HURT. MY KNEE IS NUMB ON THE SIDE NOW, IT RUNS DOWN MY LEG AND FEET. MY TOES ARE NUMB. THIS ISN'T RIGHT. I SHOULDN'T HURT LIKE THIS. I CAN'T DEAL WITH THIS ANYMORE. I CAN'T FIND ANYBODY TO HELP ME. I DON'T KNOW WHAT TO DO ANYMORE. I AM HAVING TO SEE A PSYCHIATRIST. I'M SO TIRED OF BEING IN PAIN ALL THE TIME. IS THERE ANYTHING YOU COULD DO FOR ME?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471991 MBT CEM KEEL TIB TRAY SZ4 KNEE TIBIAL TRAY NJL DEPUY (IRELAND) 9616671 2967901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention