Vericel Corporation adverse event and safety findings Skip to content

Intended for U.S. health care professionals only

To Report an Adverse Event, Medical Device Report, Other Safety Finding or Product Complaint: 

Call: 1-800-453-6948
Email: [email protected]

Vericel is committed to patient safety. Part of our mission to serve patients includes collecting, reviewing and reporting all adverse events, other safety findings, medical device reports and product complaint information associated with the use of Vericel’s investigational and marketed products.

It is Vericel’s policy to comply with all regulations and laws relating to reporting adverse events, other safety findings, medical device reports and product complaints.

Adverse Event (AE)

An AE is any untoward medical occurrence in a patient administered a Vericel product and which is not necessarily caused by the Vericel product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:

  • Any clinically significant worsening of a pre-existing condition;

  • An AE that has been associated with the discontinuation of the use of a product; and
  • Any lack or loss of intended effect.

Other Safety Findings

The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Vericel:

  • Use of a Vericel product while pregnant and/or breast feeding
  • Accidental or intentional medication errors or overdose of a Vericel product
  • Misuse, where the Vericel product is intentionally and inappropriately used including misuse for illegal purposes
  • Abuse, which is, intentional excessive use of a Vericel product
  • Transmission of an infectious agent through a contaminated Vericel product
  • Occupational exposure to a Vericel product (e.g., a Healthcare Provider is splashed with medicinal product while preparing an injection)
  • Reports of patient "death" after exposure to a Vericel product where no other details are provided (e.g. fatal outcomes)
  • Off-label use of a Vericel product (e.g. a product is intentionally used to treat a condition for which the product is not indicated).

Medical Device Report (MDR)

The following are considered MDRs

  • An event that reasonably suggests that the Vericel device:
    • May have caused or contributed to a death or serious injury including events occurring as a result of:
      • Failure
      • Malfunction
      • Improper or inadequate design
      • Manufacture
      • Labeling
      • User error
    • Has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

Product Complaints (PC)

A PC includes any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug, combination product, or device after it is released for distribution to market or clinic by either Vericel or by distributors and partners for whom Vericel manufactures the material. This includes all components distributed with the drug such as packaging, drug containers, delivery system, labelling, inserts, etc. Examples include:

  • Device that is damaged or broken

  • Bent or dull needles
  • Missing or illegible labeling
  • Inability of customer to administer the product
  • Product with an unexpected color, appearance, or particles

Indication and Important Safety Information

Important Safety Information

MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.

The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.

Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.

Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.

To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.

Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.

The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.

Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.

The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.

Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.

Please see Full Prescribing Information for more information.


MACI® is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.

The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.

Limitations of Use

Effectiveness of MACI in joints other than the knee has not been established.

Safety and effectiveness of MACI in patients over the age of 55 years have not been established.