Stryker Shoulder Implant Injury
Product liability attorney investigates defective Stryker shoulder implants for injured plaintiffs nationwide
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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. Stryker 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 Reunion TSA Peg Alignment Sound device. The 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 product liability lawyer and medical device lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.
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 Stryker Shoulder Implants
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
• Inflammation
• Implant failure
• Adverse tissue reactions
• Joint instability
• Infection
• Nerve damage
Stryker Shoulder 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 recalled Stryker products. Some of Stryker’s recalls for 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 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
• Radio-Capitellum
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 products like TSA shoulder systems allegedly 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.
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Why are these cases important?
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
Questions about Medical Device Litigation
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a product: (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)
Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).
A manufacturing defect is based on a defect that occurred during the manufacturing process. Many medical device companies have been involved in this kind of product liability lawsuits in recent years.
Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.
The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care. Ohio Revised Code 2307.74.
Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by the FDA and other federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.
Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:
The FDA, however, may initiate recalls of dangerous products but does not provide remedies or compensation for damages where an individual is injured due to the defective medical device.
Medical Devices Lawsuits
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