Vericel Corporation adverse event and safety findings Skip to content

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 should not be used if you:

  • are allergic to antibiotics such as gentamicin, or materials that come from cow, pig, or ox;
  • have severe osteoarthritis of the knee, other severe inflammatory conditions, infections or inflammation in the bone joint and other surrounding tissue, or blood clotting conditions;
  • have had knee surgery in the past 6 months, not including surgery for obtaining a cartilage biopsy or a surgical procedure to prepare your knee for a MACI implant;
  • or cannot follow a doctor-prescribed rehabilitation program after your surgery

Consult your doctor if you have cancer in the area of the cartilage biopsy or implant as the safety of MACI is not known in those cases.

Conditions that existed before your surgery, including meniscus tears, joint or ligament instability, or alignment problems should be evaluated and treated before or at the same time as the MACI implant.

MACI is not recommended if you are pregnant.

MACI has not been studied in patients younger than 18 or over 55 years of age.

Common side effects include joint pain, tendonitis, back pain, joint swelling, and joint effusion.

More serious side effects include joint pain, cartilage or meniscus injury, treatment failure, and osteoarthritis.

Please see Full Prescribing Information for more information.


MACI® is made up of your own (autologous) cells that are expanded and placed onto a film that is implanted into the area of the cartilage damage and absorbed back into your own tissue.

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is made up of your own (autologous) cells that are expanded and placed onto a film that is implanted into the area of the cartilage damage and absorbed back into your own tissue.

MACI is used for the repair of symptomatic cartilage damage of the adult knee.

The amount of MACI applied depends on the size of the cartilage damage. The MACI film is trimmed by your surgeon to match the size and shape of the damage, to ensure the damaged area is completely covered.

Limitations of Use

It is not known whether MACI is effective in joints other than the knee.

It is not known whether MACI is safe or effective in patients over the age of 55 years.