BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOKNEE

    MDR report key: 16286794 · Received February 2, 2023

    Report

    Report Number
    3014273644-2022-00001
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    August 3, 2021
    Report Date
    February 1, 2023
    Manufacturer
    NOVOSOURCE, LLC
    Product Code
    JWH
    UDI-DI
    00811382031809
    PMA / PMN Number
    K131398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RESPONSE IS PREDICATED ENTIRELY ON THE PATIENT'S ALLEGED INJURIES. NOVOSOURCE, LLC IS FILING THIS RESPONSE PURELY OUT OF AN ABUNDANCE OF REGULATORY CAUTION. WE HAVE FOLLOWED OUR EQUALITY MANAGEMENT SYSTEM WHICH HAS LED US TO CONCLUDE THAT A RESPONSIVE FILING IS UNNECESSARY. HOWEVER, SINCE THIS HAS BEEN REPORTED TO MEDWATCH WE BELIEVE A RESPONSE IS APPROPRIATE IN THIS INSTANCE. IN FILING THIS RESPONSE NOVOSOURCE, LLC MAKES NO ADMISSION WHATSOEVER THAT OUR IMPLANT IS THE CAUSE OF OR HAS CONTRIBUTED IN ANY MANNER TO THE ALLEGED COMPLAINTS ENUMERATED IN THE PATIENT'S REPORT. AS THE FDA 3500-SERIES FORM WAS INCORRECTLY COMPLETED BY THE PATIENT (INITIAL REPORTER) AND NOT QUALIFIED MEDICAL PERSONNEL, NO ADDITIOANL INFORMATION WAS GIVEN ON OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS. NOVOSOURCE, LLC GENERATED AN APPROPRIATE COMPLAINT FORM, COMPLETED A MEDICAL DEVICE REPORTING ASSESSMENT, INVESTIGATED POTENTIAL ROOT CAUSE, AND REVIEWED ALL AVAILABLE RECORDS (I.E. DHR DOCUMENTATION, DESIGN RECORDS, AND RISK DOCUMENTATION). A ROOT CAUSE COULD NOT BE EFFECTIVELY DETERMINED, HOWEVER KNEE PAIN IS A COMMON SIDE EFFECT OF TOTAL KNEE IMPLANT.

    Description of Event or Problem · 0

    MEDWATCH FORM 3500 COMPLETED BY PATIENT. DESCRIPTION OF EVENT OR PROBLEM IN THE REPORTERS OWN WORDS TRANSCRIBED FROM REPORT NUMBER MW#5111413: I HAD A TOTAL KNEE REPLACEMENT ON "(B)(6) 2021" HAVE HAD SWELLING AND SEVERE PAIN. ON (B)(6) 2022 I WENT TO MY SURGEON AND HE DID X-RAYS, AND BLOOD WORK SAID EVERYTHING WAS FINE. THEN I WENT BACK TO HIM AGAIN (B)(6) 2022 AND HE DRAINED FLUID OFF MY KNEE AND ORDERED A BONE SCAN FOR (B)(6) 2022 I WAITED UNTIL MY NEXT APPOINTMENT WITH HIM ON (B)(6) 2022 HE THEN TOLD ME THAT MY KNEE WAS LOOSE AND I WOULD HAVE TO HAVE REVISION SURGERY. MY HUSBAND ASKED HIM WHAT ABOUT IF THIS DOESN'T WORK HE THEN SAID HE WOULD JUST HAVE TO AMPUTATE ABOVE THE KNEE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371536 NOVOKNEE TOTAL KNEE JWH NOVOSOURCE, LLC 3101-1202 COR0022 00811382031809

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other