Shoulder Replacement Lawsuit Alleges Depuy Global Advantage System Prone to Loosening, Fracture

Published on November 1, 2018 by Sandy Liebhard

A Texas resident has filed a new shoulder replacement lawsuit, following the alleged failure of DePuy Orthopaedics Inc’s Global Advantage Total Shoulder Implant System.

According to a complaint filed in the U.S. District Court, Western District of Texas, on October 30^th, Leland Hamilton underwent right shoulder replacement surgery with the DePuy Global Advantage System in August 2012. (Case No. 18-190)

DePuy Shoulder Replacement Complications

He claims to have experienced pain, loss of range of motion, and loosening of the components. During shoulder replacement revision surgery in September 2016, his doctor discovered that the device’s glenoid component had fractured and was lying loose in the joint.

Hamilton’s lawsuit alleges that DePuy failed to warn doctors about the risks associated with the system, including “a propensity of poor bone ingrowth and/or fixation and the propensity of the implant to become loose and/or fracture during ordinary and foreseeable use.”

Hamilton further claims that the Global Advantage Total Shoulder Implant System is unreasonably dangerous and defective, and was never adequately tested. He also maintains that DePuy failed to instruct surgeons on the safe use of the components.

“Defendants failed to timely and reasonably warn of material facts regarding the safety and efficacy of the DePuy Global Advantage Total Shoulder System,” the lawsuit states.  “Had they done so, proper warnings would have been heeded and no health care professional including Plaintiff’s physician would have used the DePuy Global Advantage Total Shoulder System, and no consumer, including Plaintiff would have purchased used the DePuy Global Advantage Total Shoulder System.

Shoulder Replacement Complications and Revision Surgery

The DePuy Global Advantage Total Shoulder Implant System came to market via the U.S. Food & Drug Administration’s 510(k) clearance program. This “fast-track” process allows device manufacturers to avoid conducting human clinical trials as long as they can show a new device is “substantially equivalent” to an implant that has already been subjected to the FDA’s more stringent pre-market approval process.

Some 53,000 people in the United States opt to undergo shoulder replacement every year.

The procedure is performed when pain-relieving drugs and activity changes no longer alleviate shoulder discomfort due to:

• Osteoarthritis
• Rheumatoid arthritis
• Post-traumatic arthritis
• Rotator cuff tear arthropathy
• Osteonecrosis
• Severe fractures
• Previous failed shoulder replacement

Ideally, a shoulder replacement should last 10 years. However, premature failure can occur, usually due to:

• Infection
• Rotator cuff damage
• Bone Fracture.
• Joint dislocation or partial dislocation
• Component erosion
• Nerve injuries
• Allergic reaction to cement or joint prosthesis

Patients who experience shoulder replacement failure require revision surgery, a far more complex procedure compared to an initial implant surgery. As such, shoulder replacement revision is more likely to result in serious complications, including infection, bleeding, nerve damage, and trauma to blood vessels are possible. What’s more, some individuals will not be able to return to their normal level of function following surgery.