Tornier Shoulder Replacement

Tornier, Inc. designs, manufactures and markets a wide array of joint replacement and tissue repair devices. Tornier shoulder replacement products include the Ascend, Aequalis Ascend Flex, and Simpliciti lines.

Tornier Ascend Shoulder System

Cleared by the U.S. Food & Drug Administration (FDA) in 2012, the Ascend Shoulder System consists of a titanium humeral stem (either Titanium Plasma Spray coated or un-coated version), a mating humeral head, and an optional polyethylene glenoid (socket).  The Ascend System is indicated for use in patients who require shoulder replacement due to:

  • Rheumatoid arthritis with pain
  • Non-inflammatory degenerative joint disease
  • Correction of functional deformity
  • Fractures of the humeral head
  • Traumatic arthritis
  • Revision (if sufficient bone remains)

The Ascend Shoulder System is only indicated for use in patients with an intact or reconstructable rotator cuff.

Tornier Aequalis Ascend Flex

Tornier’s Aequalis Ascend Flex System was initially cleared by the FDA in 2013, and may be used in primary, reverse, or conversion (from anatomic to reverse) procedures. It is indicated for patients who require shoulder replacement due to:

  • Rheumatoid arthritis with pain
  • Non-inflammatory degenerative joint disease
  • Correction of functional deformity
  • Fractures of the humeral head
  • Traumatic arthritis
  • Revision (if sufficient bone remains)

The Aequalis Ascend Flex Shoulder System consists of various components, depending on the configuration. Some of these include a titanium humeral stem (either Titanium Plasma Spray coated or un-coated version), as well as a cobalt-chromium humeral head with a compatible glenoid.

The Aequalis Ascend Flex System is intended to be used in individuals who have a functional deltoid muscle with a massive, non-repairable rotator cuff tear.

Tornier Simpliciti

Cleared by the FDA in 2015, the Tornier Simpliciti Shoulder System is indicated for total shoulder replacement in patients who have a severely painful and/or disabled joint as a result of osteoarthritis or traumatic arthritis. The metaphyseal humeral stem, which is constructed of titanium alloy, is indicated for press-fit, uncemented use. The humeral heads are made of cobalt-chromium- alloy. The polyethylene glenoid components are indicated for cemented use only.

In a press release announcing its FDA clearance, Tornier characterized the Simplicity System as a “novel, first to market system in the United States” which would provide “surgeons with an efficient, repeatable surgical technique that is intended to preserve both the patient’s native bone and avoid further trauma to the surrounding soft tissue.”

Shoulder Replacement Complications

Complications that may be associated with any type of shoulder replacement surgery include:

  • Infection: A minor shoulder replacement infection can be treated with antibiotic therapy. However, more serious conditions may require revision surgery to remove or replace the shoulder.
  • Prosthesis issues: Loosening, dislocation, excessive wear and other problems with shoulder components could make revision surgery a necessity.
  • Nerve injuries: Shoulder replacement procedures may result in some nerve damage. However, these injuries often resolve over time.
  • Metal toxicity: Due to the shedding of metal particles as a result of component wear.
  • Bone and tissue damage
  1. FDA (2012) “Ascend Shoulder System 510(k) Summary” http://www.accessdata.fda.gov/cdrh_docs/pdf12/K120794.pdf
  2. FDA (2013) “Aequalis Ascend Flex Shoulder System (510(k) Summary) https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122698.pdf
  3. FDA (2015) “Simpliciti Shoulder System 510(K) Summary http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143552.pdf
Last Modified: September 20, 2016

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