decor

Stryker Hip Replacement Lawsuits

All hip replacements come with risks, and if your doctor thinks a replacement could help you function better, they will review your options before deciding on a replacement. However, some products have undergone consumer recalls, and their manufacturers are involved in pending litigation. Stryker is a US-based company that manufactures hip replacement products and has been named in several lawsuits regarding their products.

Sign up for our newsletter to get updates on drugs & medical devices

If you would like to sign up for our newsletter click the button below.

Sign Up For Newsletter

Why Are People Filing Stryker Hip Replacement Lawsuits?

Like many other hip replacement device manufacturers, Stryker has faced litigation regarding damages and complications caused by metal-on-metal (MoM) hip replacement devices. Although Stryker claims their systems are not true MoM devices as the entire product is not made of metal, the components coated in metal coming in contact with each other result in the same complications as complete MoM devices. Research has shown that the wear occurring from metal-on-metal devices releases metal ions in the body leading to metallosis and other severe bodily damage. In addition, patients have accused Stryker of knowing about the risks associated with metal-on-metal devices for years without informing patients or healthcare providers of the risks. 

Stryker is facing litigation related to the increased need for revision surgery for multiple hip replacement products.

Which Stryker Hip Replacement Systems Have a High Failure Rate?

Several devices manufactured by Stryker are facing lawsuits due to their high failure rate.

They include:

  • Rejuvenate-2012
  • ABG II-2012
  • Meridian TMZF Stem
  • Citation TMZF Stem-2014
  • Accolade TMZF-2011
  • LFIT V40 Femoral Head-2015
  • Tritanium Acetabular Shell

The company has recalled nearly 100,000 devices since 2011.

What Are Signs of Malfunctioning Hip Replacement Products?

While some hip replacement failures occur without negligence or fault. Some are caused due to a malfunction in the replacement products used during the surgery.

Symptoms you may experience due to a defective replacement product include:

  • continued joint pain
  • damaged bone tissue, medically termed osteolysis
  • metal debris accumulation in the area around the product, or metallosis
  • development of pseudotumors, which are soft tissue masses occurring near the artificial parts
  • hip dislocation

What Types of Treatment Are Available for Malfunctioning Hip Replacement Products?

Secondary surgery is required if hip replacement failure occurs due to natural causes or defective products. This surgery is called revision surgery. If a revision is necessary due to malfunctioning replacement products, those products will need to be replaced with working artificial parts. In addition, symptoms such as metallosis, osteolysis, and pseudotumors will need to be treated in addition to replacing defective products. 

Have the Defective Stryker Hip Replacement Systems Been Recalled?

Since 2011 Stryker has initiated hundreds of recalls with the FDA. As a large multinational corporation providing a broad range of products for multiple medical disciplines, many of these recalls are unrelated to their hip replacement products. However, five Stryker hip replacement products have been recalled in this timeframe.

These products are:

  • LFIT V40 Femoral Head-2015
  • Citation TMZF Stem-2009
  • Rejuvenate-2012
  • ABG II-2012
  • Accolade TMZF-2011

These recalls focus primarily on the failure rate of the replacement products due to metal-on-metal product design. However, the Accolade TMZF recalls were mostly due to packaging or manufacturing errors. Due to the high failure rate of these systems, multiple individual lawsuits and three mass litigation lawsuits have been filed.

Why Were the ABG II and Rejuvenate Systems Recalled? 

The Stryker Rejuvenate modular-neck stem for hip replacement surgery was approved by the U.S. Food and Drug Administration (FDA) in June 2008. The Stryker ABG-II modular-neck stem device was approved in November 2009. Both products were marketed for younger patients and advertised as high-performance devices intended to be more durable and longer-lasting. 

The devices were designed to model the biomechanics and anatomy of the human hip and to provide enhanced stability. Additionally, they were both engineered as modular units to make implantation easier for the physician who could choose components to best fit a particular patient. The Rejuvenate system included 6 stems and 16 necks, while the ABG-II system had 8 right stems, 8 left stems, and 10 necks for various configurations.

The Rejuvenate and ABG-II systems were not designed as strictly metal-on-metal implants, which had already been shown to be problematic but were supposed to resist metal fatigue and corrosion. Unfortunately, patients were still exposed to significant risks caused by the devices’ construction of titanium, zirconium, molybdenum, and iron.

Both the Rejuvenate and ABG-II hip replacement devices were recalled in 2012 and discontinued within three years of introduction due to an abnormally high number of cases of metallosis and other side effects caused by corrosion and fritting of the modular-neck stems.

Why Was the LFIT V40 Femoral Head Recalled?

The Stryker LFIT V40 Femoral Head is a part of Stryker’s modular system, which is used in replacement surgery to replace the top portion of the large leg bone or femur. It was approved in 2001 and was designed to be used as a component with other Stryker components. The LFIT V40 device is constructed of the metals cobalt and chromium, which were believed to be exceedingly durable and relatively safe. In addition, the design was intended to match patient anatomy and mimic natural biomechanics to increase the range of motion and reduce dislocation events.

 Unfortunately, in 2016, Stryker was forced to recall multiple model numbers of the LFIT V40 (CoCr) Femoral Head devices due to a high risk of taper lock failure. Failure of the femoral head could lead to hip dislocation, unseating of the head from the leg bone, fracture of the hip or leg, increased metallic debris, and other complications. Therefore, in 2017, the LFIT recall was expanded to include additional devices from the same line.

Why Was the Citation TMXF Hip Stem Recalled?

The Citation TMXF hip stem was initially recalled in 2009 due to manufacturing errors which resulted in the products failing to meet company quality standards. Additionally, the Citation TMXF hip stem was included in the recall for the LFIT V40, as it could be used in conjunction with that product.

How Many Stryker Hip Replacement Lawsuits Have Been Filed?

Stryker has faced thousands of lawsuits regarding their hip replacement products, particularly for the ABG II and Rejuvenate implants. Additionally, hundreds of lawsuits have been filed for the LFIT V40 Femoral Head.

Currently, complications from the Tritanium Acetabular Shells are being investigated for litigation. Therefore, patients with Stryker hip implant devices are encouraged to notify their doctors if they experience any issues with pain, discomfort, lack of mobility and range of motion, flu-like symptoms, or other complication. 

What Stryker Hip Replacement Lawsuit Settlements Have There Been?

In 2014 Stryker paid over $2 billion in settlements for the ABG II and Rejuvenate system lawsuits. However, as of October 2022, there are still 81 lawsuits pending in Minnesota Federal Court as multidistrict litigation for these systems.

The LFIT V40 Femoral Head lawsuits were filed in Minnesota and New Jersey. The New Jersey suits were formed into multicounty litigation. Although a confidential settlement was reached regarding the cases for the LFIT V40 Femoral Head in 2018, there are still 581 lawsuits pending mass litigation in Minnesota.

What Stryker Hip Replacement Class Action Lawsuits Are There?

There are no current class action lawsuits against Stryker regarding their hip replacement devices. However, multi-district litigation (MDL) and multi-county litigation (MCL) suits have been created. This type of litigation occurs when lawsuits from different locations are consolidated and transferred so that one judge can hear all the cases at once. This is typically done to speed up litigation when cases are more complex. The MDL and MCL lawsuits for the ABG II, Rejuvenate, and LFIT V40 have reached initial settlements. However, all still have cases pending.

Who Qualifies for a Stryker Hip Replacement Lawsuit?

Patients whose Stryker hip replacement devices were recalled or faulty may be eligible to file a lawsuit against Stryker Corporation to recover from the financial damages incurred. Lost wages, hospital bills, and other medical expenses are some of the damages that Stryker hip replacement patients may be entitled to receive. If you are still determining if the hip implant device used in your surgery is part of the recalled products, reach out to your doctor immediately. Do not wait for the hip implant to fail or malfunction.

How Do I Find a Hip Replacement Attorney?

If your Stryker hip replacement device has been recalled and you’ve learned from your doctor that the cause of your adverse side effects was due to defects in the device, you should contact a Stryker hip replacement lawyer. Law firms like Seeger Weiss specialize in litigation against large corporations like Stryker.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

Sources

  1. Failed total hip replacement. Clohisyhipsurgeon.com. (n.d.). Retrieved January 15, 2023, from https://clohisyhipsurgeon.com/conditions-treated/failed-total-hip-replacement 
  2. Is your device in the International Medical Devices Database? International Medical Devices Database. (n.d.). Retrieved January 29, 2023, from https://medicaldevices.icij.org/devices/usa-orthopedic-devices-device-recall-citation-tmzf-ha-stem-b94e2d5c 
  3. Jonathan Cluett, M. D. (2022, March 11). Do you know who made your joint implant? Verywell Health. Retrieved January 15, 2023, from https://www.verywellhealth.com/orthopedic-implant-supply-companies-4156292
  4. Medical device recalls. accessdata.fda.gov. (n.d.). Retrieved January 29, 2023, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm 
  5. Merola, M., & Affatato, S. (2019, February 5). Materials for hip prostheses: A review of wear and loading considerations. Materials (Basel, Switzerland). Retrieved January 15, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6384837/#:~:text=Most%20used%20are%20titanium%20alloys,of%20metals%2C%20ceramics%20or%20polymers 
  6. Metallosis of the resurfaced H – seattlejointsurgeon.com. (n.d.). Retrieved January 16, 2023, from https://www.seattlejointsurgeon.com/system/resources/W1siZiIsIjIwMTkvMDYvMjEvMTUvMzgvNDYvNGE4MGRjODYtMmQ2Mi00Y2ZlLWE4MGItZDhkMDRlYjQyNTVlL21ldGFsbG9zaXMtb2YtcmVzdXJmYWNlZC1oaXAucGRmIl1d/metallosis-of-resurfaced-hip.pdf 
  7. Perriello, B. (2016, November 17). Stryker recalls Modular SMF, Modular REDAPT Hip implants. MassDevice. Retrieved January 15, 2023, from https://www.massdevice.com/smith-nephew-recalls-modular-smf-modular-redapt-hip-implants/#:~:text=Smith%20%26%20Nephew%20recalls%20Modular%20SMF%2C%20Modular%20Redapt%20hip%20implants,-November%2017%2C%202016&text=Smith%20%26%20Nephew%20(NYSE%3ASNN,necks%20used%20in%20the%20devices 
  8. Stryker Orthopaedics. (n.d.). Our history. Stryker. Retrieved January 28, 2023, from https://www.stryker.com/us/en/about/history.html 
  9. Stryker. (n.d.). Modular rationale and surgical technique. Retrieved January 28, 2023, from https://www.hpcbd.com/wp-content/uploads/migrations/2061991/ABG-II-Modular-Rationale-and-Surgical-Technique.pdf 
  10. Springer, B. D., Fehring, T. K., Griffin, W. L., Odum, S. M., & Masonis, J. L. (2009, January). Why revision total hip arthroplasty fails. Clinical orthopaedics and related research. Retrieved January 15, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600991/ 
  11. U.S. Department of Health and Human Services. (2022, August 3). Niams health information on hip replacement. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Retrieved January 13, 2023, from https://www.niams.nih.gov/health-topics/hip-replacement-surgery