BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOVERA - RIGHT KNEE CRYONEUROLYSIS

    MDR report key: 24445017 · Received February 25, 2026

    Report

    Report Number
    MW5184403
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    November 16, 2024
    Report Date
    February 20, 2026
    Manufacturer
    PACIRA PHARMACEUTICALS, INC.
    Product Code
    GXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 - HAD 6 INJECTION (IOVERA) CRYONEUROLYSIS AT (B)(6). THIS WAS PERFORMED BY AN ANESTHESIOLOGIST 2 WEEKS BEFORE MY KNEE REPLACEMENT SURGERY ON (B)(6) 2024. IT HAS BEEN A YEAR AND A HALF SINCE MY RIGHT KNEE REPLACEMENT, AND I AM STILL VERY NUMB SURROUNDING MY KNEE AND A 2ND OPINION DOCTOR'S CLINICAL OPINION IS THAT I HAVE AN UNSTABLE MCL. I AM NOT ABLE TO WALK EASILY OR GO UP AND DOWNSTAIRS. THE DOCTOR WHO DID THE SURGERY STATED THAT HIS ORTHOPEDIC GROUP HAS DISCONTINUED USING IOVERA AND OFFERS NO SOLUTION FOR TREATMENT OF NUMBNESS OR ANY OTHER SURGERY TO "ELONGATE" THE MCL. I HAVE SEEN ANOTHER DOCTOR AT (B)(6). HE ORDERED AN MRI, AND KNEE REPLACEMENT SHOWED INTACT. HE HAS SUGGESTED TO SEE A VASCULAR SURGEON WHO WILL DO AN ULTRASOUND OF MY LEG NEXT MONTH. KNEE REPLACEMENT INTACT. MY NUMB NERVE(S) NOT ADDRESSED AS TO CAUSE, AND VASCULAR SURGEON SUGGESTED FOR CONSIDERATION BY ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505803 IOVERA - RIGHT KNEE CRYONEUROLYSIS DEVICE, SURGICAL, CRYOGENIC GXH PACIRA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other