DePuy Orthopaedics Hip Replacements

DePuy is one of the largest manufacturers of hip replacements in the world. It sells individual hip implant components such as femur stems, femoral heads, and acetabular cups in addition to complete hip replacement systems. Some DePuy hip implants have been recalled or discontinued because they caused unexpected complications, but DePuy continues to offer other effective hip implants.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

DePuy Orthopaedics is a subsidiary of Johnson & Johnson. The company, founded in 1895, merged with Syntheses in 2011 to become DePuy Syntheses. It has more than 200 orthopedic products, including hip, knee and shoulder replacements.

DePuy’s top hip reconstruction products include the Tapered Hip System, the Total Hip System and Hip Solutions modular cups.

Other hip replacement products include:

  • Total Hip System
  • Pinnacle Revision Acetabular Cup System
  • Modular Revision Hip System
  • Bone Preservation Stem

More than one million patients have received Pinnacle Hip Solutions cups, according to DePuy. The devices are implanted into the pelvis during partial or total hip replacement surgeries to relieve pain or increase mobility. Today, the Pinnacle cups come in ceramic-on-polyethylene and metal-on-polyethylene options depending on patient needs.

Tapered Hip System stems have been used for more than 15 years to attach hip implants to the femur. A 2010 study found that only one out of 96 people who received the device required a revision surgery and that person required surgery after a fall. The implants come in cemented and cementless options.

Stems from the Total Hip System have been implanted in more than 1.6 million patients across the world. The products include cemented or cementless stems and femoral heads.

DePuy has several products with a history of safety and effectiveness, but some of its products have been scrutinized and recalled for ineffectiveness. In 2010, DePuy recalled its ASR XL Acetabular System and ASR Hip Resurfacing System because a large number of patients required revision surgery after receiving the implants.

The company also stopped selling the all-metal versions of the Pinnacle system of implants because large numbers of consumers claimed the devices were faulty and led to a type of metal poisoning called metallosis.

Close up of a metal hip
Close up view of a metal hip

DePuy’s ASR XL Acetabular and Hip Resurfacing Systems

The DePuy ASR XL Acetabular System and ASR Hip Resurfacing System were used in more than 93,000 hip replacement surgeries internationally. Both systems were members of a class of large-diameter hip resurfacing and replacement devices created from a single sheet of metal.

The metal-on-metal systems were designed to be more durable than other systems, but they resulted in serious complications.

The ASR XL System was launched in the United States in 2005. It was designed to be used for total hip replacements. The ASR Hip Resurfacing System was sold internationally beginning in 2003. It was intended to be used in hip resurfacing procedures, which eliminate less natural hip structure than total hip replacements.

However, DePuy recalled the products in 2010 after receiving data from the National Joint Registry of England and Wales indicating the devices had higher-than-normal failure rates. Months later, the British Orthopaedic Association and the British Hip Society reported even higher failure rates.

By 2012, Johnson & Johnson had budgeted $3 billion to settle more than 3,000 lawsuits involving the ASR hip replacement systems, according to Reuters. A year later, the company settled thousands of ASR hip lawsuits for $4 billion.

Pinnacle Hip Replacement System

The Pinnacle system was approved by the U.S. Food and Drug Administration in 2000.

It included several types of ball-and-socket surfaces, including:

  • Ceramic-on-polyethylene
  • Ceramic-on-ceramic
  • Metal-on-polyethylene
  • Metal-on-metal
  • Ceramic-on-metal

Surgeons were allowed to select a model that met the unique needs of each patient receiving a hip implant. Components made from more durable material, such as metal, were supposed to be suitable for young patients who were likely to live active lifestyles.

The cup liner used in the Pinnacle metal-on-metal components was approved by the FDA based on a nearly identical DePuy product that had already been approved: the Ultima Metal-On-Metal Acetabular Cup.

However, the design was faulty. A 2010 study published in the Journal of Bone and Joint Surgery revealed that the Ultima metal liner failed in 14 percent of patients. During revision surgery, doctors found several unexpected complications, such as cloudy fluid in pockets in the hip, severe necrosis (tissue death) and ruptured tendons.

The Pinnacle and Ultima metal liners cause friction between the cup and the ball-shaped replacement head of the thigh bone. This can cause the device to prematurely erode and release metal ions that cause a type of metal poisoning called metallosis.

By 2012, almost 1,600 lawsuits were filed against DePuy involving Pinnacle implants. The company never recalled the Pinnacle products, but it stopped selling the metal-on-metal components in 2013. In 2016, the company lost a pair of multi-million dollar verdicts and was ordered to pay damages of $1 billion and $502 million to two groups of patients, according to Bloomberg.

Despite having to discontinue multiple faulty products, DePuy remains an industry leader in the hip replacement market. The company’s hip device sales generated $1.3 billion in annual revenue from 2013 to 2015, and its devices are used in hip replacement procedures every day.

Author

Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields. He graduated from the University of West Florida with a master’s degree in Strategic Communication and Leadership, a graduate-level certificate in Health Communication Leadership and a bachelor’s degree in Journalism.


Hide Sources

  1. Dalury, D.F., Gonzales, R.A. & Adams, M.J. (2010, January). Minimum 5-year results in 96 consecutive hips treated with a tapered titanium stem system. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/19056225
  2. DePuy Synthes. (n.d.). About DePuy Synthes Companies. Retrieved from https://www.depuysynthes.com/about/depuy-synthes-joint-reconstruction
  3. DePuy Synthes. (n.d.). Pinnacle Hip Solutions. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/PINNACLE-Hip-Solutions
  4. DePuy Synthes. (n.d.). Pinnacle Hip Solutions Design Rationale. Retrieved from https://258413772373414384.s3.amazonaws.com/pdf/2013/11/DPY_Pinnacle_Hip_Solutions_EO-12920pdf.pdf
  5. DePuy Synthes. (n.d.). Pinnacle Acetabular Cup System. Retrieved from https://www.depuysynthes.com/patients-and-caregivers/hip/pinnacleclinical.html
  6. DePuy Synthes. (n.d.). Summit Tapered Hip System. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/SUMMIT-Tapered-Hip-System
  7. DePuy Synthes. (n.d.). Summit Tapered Hip System. Retrieved from http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/Summit%20Design%20Rationale%20and%20Surgical%20Technique.pdf
  8. DePuy Synthes. (n.d.). Corail Total Hip System. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/CORAIL-Hip-System
  9. DePuy Synthes. (n.d.). Corail Hip System Product Rational and Surgical Technique. Retrieved from http://www.corailpinnacle.net/sites/default/files/2016-04/corail-product-rationale-and-surgical-technique.pdf
  10. DePuy Synthes. (n.d.). Actis Total Hip System. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/ACTIS-Total-Hip-System
  11. DePuy Synthes. (n.d.). Pinnacle Revision Acetabular Cup System. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/PINNACLE-Revision-Acetabular-Cup-System
  12. DePuy Synthes. (n.d.). Reclaim Modular Revision Hip System. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/RECLAIM-Modular-Hip-System
  13. DePuy Synthes. (n.d.). Tri-lock Bone Preservation Stem. Retrieved from https://www.depuysynthes.com/hcp/hip/products/qs/TRI-LOCK-Bone-Preservation-Stem
  14. DePuy Synthes. (2011, April 27). Johnson & Johnson and Synthes Announce Definitive Merger Agreement – DePuy. Retrieved from https://www.depuysynthes.com/about/news-press/qs/johnson--johnson-and-synthes-announce-definitive-merger-agreement---depuy
  15. DePuy Synthes. (2010, August 26). DePuy Orthopaedics Voluntarily Recalls ASR Hip System – DePuy. Retrieved from https://www.depuysynthes.com/about/news-press/qs/depuy-orthopaedics-voluntarily-recalls-asr-hip-system---depuy
  16. Donell, S.T., et al. (2010, November). Early Failure of the Ultima Metal-on-metal Total Hip Replacement in the Presence of Normal Plain Radiographs. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21037343
  17. Feeley, K. & Korosec, T. (2016, December 1). J&J Ordered to Pay Record $1 Billion for Faulty Hip Implants. Retrieved from https://www.bloomberg.com/news/articles/2016-12-01/j-j-ordered-to-pay-more-than-1-billion-for-pinnacle-hip-device
  18. Hodgkinson, J., Skinner, J. & Kay, P. (n.d.). Large Diameter Metal on Metal Bearing Total Hip Replacements. Retrieved from https://www.britishhipsociety.com/uploaded/BHS_MOM_THR.pdf
  19. Johnson & Johnson. (2016, March). Annual Report 2015. Retrieved from http://files.shareholder.com/downloads/JNJ/1709744668x0x881109/474857DD-8E67-43B1-BB38-0A9712D93545/2015_annual_report_.pdf
  20. Kavilanz, P. (2010, August 26). J&J Unit Recalls 93,000 Hip Implant Systems. Retrieved from http://money.cnn.com/2010/08/26/news/companies/johnson_depuy_hipsystem_recall/
  21. Korosec, T. & Feeley, J. (2016, March 17). J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures. Retrieved from https://www.bloomberg.com/news/articles/2016-03-17/j-j-ordered-to-pay-502-million-over-pinnacle-hip-failures-ilwk16v4
  22. Meier, B. (2010, March 9). With Warning, a Hip Device Is Withdrawn. Retrieved from http://www.nytimes.com/2010/03/10/business/10device.html
  23. Meier, B. (2013, January 22). Maker Aware of 40% Failure in Hip Implant. Retrieved from http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html
  24. Meier, B. (2013, November 12). Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants. Retrieved from http://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html
  25. Sherman, D. (2012, July 12). Insight: As Lawsuits Climb, J&J May Have New Hip Trauma. Retrieved from http://www.reuters.com/article/us-johnsonandjohnson-implants-idUSBRE86B06020120712
Free DePuy Case Review

Are you experiencing complications after undergoing a total hip replacement?
Get Help Now