BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT KNEE

    MDR report key: 15210048 · Received August 10, 2022

    Report

    Report Number
    MW5111413
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 8, 2022
    Manufacturer
    NOVOSOURCE, LLC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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
    1941618 REPLACEMENT KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH NOVOSOURCE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other| R| S AMLODIPINE/BENAZEPRIL5-40 MG 1 TABLET PER DAY| ESCITALOPRAM 20 MG 1 TABLET PER DAY| FUROSEMIDE 40 MG 1 TABLET PER DAY| LORAZEPAM 2 MG 1 TABLET X 2 PER DAY| LOW DOSE ASPIRIN 80 MG 1 TABLET PER DAY| NAPROXEN 500 MG 1 TABLET 2X PER DAY | PERSERVISION ARED 2VITAMINS 1 TABLET 2X PER DAY| QUETINPINE 50 MG 1 TABLET PER DAY