Anika

Anika joint preservation post-market surveillance · 12 sites · as of 28 May 2026

Total events

9

All reported AEs and SAEs

Serious events

3

SAE, SADE, and USADE

Pending action

7

3 expedited open

Closed

2

Sponsor sign-off complete

How the AE/SAE workflow works

Each adverse event follows a five-stage ISO 14155-aligned process. Investigators report and assess events at site; Anika classifies, follows up, and signs off as sponsor. Automated emails notify the right people at each step transition.

  1. 1

    Reported

    The investigator submits the initial AE report within 24 hours of becoming aware of the event.

    Investigator (site)

  2. 2

    Investigator

    The investigator assesses severity and relationship to the device or procedure.

    Principal investigator

  3. 3

    Sponsor

    The sponsor reviews the investigator assessment and formally classifies the event.

    Anika medical monitor

  4. 4

    Follow-up

    Additional clinical information is gathered until the event outcome is known.

    Investigator and sponsor

  5. 5

    Signed off

    The sponsor confirms all information is accurate and closes the report.

    Anika safety officer

Adverse events register

Drag cards between columns to advance the workflow, or click a card to review fields and email notifications. Switch to table view for sorting and export-style scanning.

Reported

1

Investigator (site)

  • AE-2026-007

    AN-1329

    Moderate joint stiffness persisting for 5 days post-injection. Physiotherapy referral made. No signs of infection.

    Unclassified
    Guy's Hospital27 May

Investigator

2

Principal investigator

  • AE-2026-003

    AN-1203

    Transient localised pain at injection site lasting approximately 6 hours. No systemic symptoms. Patient continued normal activities.

    Unclassified
    Mild
    Nuffield Health24 May

  • AE-2026-009

    AN-1088

    Localised erythema and itching at injection site. Topical antihistamine prescribed. Resolved within 48 hours.

    Unclassified
    Moderate
    Spire Leeds Hospital20 May

Sponsor

2

Anika medical monitor

  • AE-2026-004

    AN-0954

    Device deficiency noted: pre-filled syringe plunger resistance during administration. Injection completed without further incident.

    Unclassified
    Mild
    Spire Leeds Hospital22 May

  • AE-2026-005

    Expedited

    AN-1118

    Unanticipated serious adverse device effect: anaphylactic reaction within 15 minutes of injection. Epinephrine administered. Patient stabilised and discharged after observation.

    USADE
    Severe
    Royal Orthopaedic Hospital25 May

Follow-up

2

Investigator and sponsor

  • AE-2026-002

    Expedited

    AN-0876

    Serious adverse event: patient hospitalised for septic arthritis following knee injection. IV antibiotics initiated. Synovial fluid culture pending.

    SAE
    Severe
    Guy's Hospital19 May

  • AE-2026-008

    Expedited

    AN-0990

    Anticipated serious adverse device effect: deep joint infection requiring surgical washout. Classified per ISO 14155 risk analysis.

    SADE
    Severe
    Nuffield Health15 May

Signed off

2

Anika safety officer

  • AE-2026-001

    AN-1042

    Patient reported increased knee swelling and warmth 48 hours after Cingal injection. No fever. Managed with ice and elevation.

    AE
    Mild
    Royal Orthopaedic Hospital21 May

  • AE-2026-006

    AN-0731

    Mild headache and nausea reported 24 hours post-procedure. Symptoms resolved with paracetamol. No further intervention required.

    AE
    Mild
    Chelsea and Westminster Hospital11 May

Co-designed AE/SAE management with Patient Watch