Stryker Recalls Component of Defective Shoulder Implant
In December, 2016, Stryker Corporation officials sent a warning notice to orthopedic surgeons using the ReUnion TSA shoulder replacement system. According to the warning, Stryker acknowledged the device may fail during surgery. Shoulder replacement system failures may compromise the implant’s effectiveness and the patient’s health.
Stryker stated the reason for recall was that the Reunion TSA Peg Alignment Sound may break during surgery. The Peg Alignment Sound is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA prior to final implantation.
In response, the U.S. Food and Drug Administration (FDA) issued a January, 2017 recall notice for the defective Reunion TSA Peg Alignment Sound device. The defective device is manufactured by Howmedica Osteonics Corp., a subsidiary of Stryker Corporation.
This is a Class 2 recall, which the FDA issues when a product may cause “temporary or medically reversible adverse health consequences.” A Class 2 recall is the second-most serious recall classification measured by the FDA.
Anybody with a Stryker ReUnion Total Shoulder Arthroplasty (TSA) System should contact their doctor if there are symptoms of failure. Defective implant issues may require extensive and painful revision surgery.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio medical device lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.
Recall History for Stryker’s ReUnion TSA Device
This is not the first recall for the ReUnion replacement device. In 2007, Stryker recalled its shoulder prosthesis, the ReUnion Fracture Stem Humeral Component, because the plasma spray component was known to delaminate from the proximal portion of the humeral stem. Again in 2015, Stryker recalled the ReUnion model.
Stryker’s ReUnion Total Shoulder Arthroplasty (TSA) System was designed to address common arthritic disorders affecting the shoulder as well as various fractures of the proximal humerus. In most cases involving both the humeral head and the glenoid, a total shoulder arthroplasty may be performed.
However, occasional complications and post-operative issues may harm a patient’s quality of life, in contrast to the original intention to improve issues with movement and discomfort.
Complications of Shoulder Implant Device
The U.S. Food and Drug Administration (FDA) has warned in the past that certain patients with defective implants may experience the following side effects:
• Severe pain
• Implant failure
• Adverse tissue reactions
• Joint instability
• Nerve damage
Stryker Implant Recalls
Stryker is one of the largest orthopedic and device companies in the world. Stryker Corp. has around $9 billion in annual revenue. Its hip, knee, shoulder and bone products are used by millions worldwide. Unfortunately, thousands of patients have received defective Stryker products. Some of Stryker’s recalls for defective medical devices include:
• In recent years, the FDA warned Stryker that components of their Scorpio and Duracon knee implants were not conforming to manufacturing standards.
• In July, 2012, Stryker Orthopaedics recalled the Rejuvenate and the ABG II modular-neck hip stems.
• In 2013, Stryker recalled the Accolade modular system. In 2014, the company settled thousands of lawsuits for over $1 billion.
Stryker Forearm Implant Devices Recalled
Five additional medical devices manufactured by Stryker Howmedica Osteonics—the same company which produced the defective TSA system implants—were recalled in June, 2016. The five Stryker implant devices recalled include the following:
• Recon radial implant
• rHead lateral stem
• Sigmoid Notch radial plate
• uHead ulnar implant
According to the U.S. Food and Drug Administration Stryker recalled nearly 17,000 arm implant devices in August, 2015 because their packaging could have been compromised during transportation
Failing Stryker Shoulder Implant Devices
Patients who have received a Stryker Total Shoulder Arthroplasty system should consult with their implanting surgeon, especially if they experience uncommon pain, or other post-operative complications.
The FDA approval process for new medical devices has long been too lenient. As a result, many of Stryker’s defective products like TSA shoulder systems injure American consumers. Injured patients and experienced attorneys are forcing large medical device companies like Stryker to claim responsibility for the damaging products they continue to market and distribute.
Defective Shoulder Implant Lawyer
If you or a loved one suffered an injury due to a defective Stryker shoulder implant, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.