Hip Replacement Recalls

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FDA recallWith the advancement of orthopedic technology, hip replacement devices are growing in popularity. Many of these devices feature state-of-the-art technology designed to help increase mobility for hip replacement patients. A number of hip replacement recalls were issued in the past decade. These hip replacement recalls primarily took place due to metal-on-metal device designs that resulted in metallic debris and other injury for patients.

Two notable hip replacement recalls were issued for Styker and DePuy hip replacement devices. In 2012, Stryker issued a voluntary recall for its ABG II and Rejuvenate hip systems. Evidence showed that he metal-on-metal design of the implants caused bone and tissue damage that resulted in adverse local tissue reactions (ALTRs). DePuy recalled its Articular Surface Replacement (ASR) Hip Resurfacing System and ASR Acetabular hip system in 2010 for similar reasons. Research revealed a failure rate of nearly 40-percent compared to the standard failure rate of less than 10 percent.

Hip Replacement Recall Process

Hip replacement recalls function similarly to other product recalls on the U.S. market. There are three ways that a hip replacement recall can take place. In some cases, the manufacturer voluntarily issues a hip replacement recall based on evidence that the product may be harmful to users. If the U.S. Food and Drug Administration (FDA) concludes that the product is defective or harmful, it may request a recall from the manufacturer if the manufacturer fails to initiate a voluntary recall.

In extreme cases, the FDA may order a recall from the product manufacturer. If the manufacturer refuses, the FDA may take legal action against the manufacturer. Once the FDA gains legal authority, it can force a recall or seize the defective product from the manufacturer.

Hip Replacement Recall Causes

Hip replacement recalls typically take place after a number of adverse events are reported from patients. This is the case for both the Stryker and DePuy hip replacement recalls. The recalled Stryker and DePuy devices featured a metal-on-metal junction that created issues for patients. Over time, the metals rubbed together during routine daily movement. This caused the metals to corrode and fret. Metallic debris was then created and deposited at the implant site.

As a result, patients experienced a range of symptoms such as inflammation, infection, and damage to the tissue and bone surrounding the implant. Many patients developed pseudotumors, or tumor-like growths. In severe cases, the metallic ions entered the patient’s bloodstream, causing a condition called metallosis. Metallosis can cause damage to other organs such as the kidneys, heart, and thyroid. Nervous system damage may also occur from metallosis.

The FDA has cited a number of risks for hip replacement devices, including:

  • Joint infection
  • Bone fracture
  • Hip dislocation
  • Osteolysis, or bone loss
  • Loosening or breaking of the device
  • Nerve damage resulting in weakness or numbness
  • Differences in the length of a patient’s legs

Hip Replacement Revision Surgery

Many patients were forced to undergo revision surgery to correct the problems caused by the defective hip replacement devices. These operations are often expensive and painful for the patient. Due to the invasive nature of a hip implant, revision surgeries may also be difficult to perform. Patients may also experience longer recovery time as a result of hip replacement revision surgery.

Manufacturers and the FDA urge hip replacement patients to seek medical attention if they experience any pain or discomfort from these devices. Persistent pain often indicates a problem that could result in tissue damage and other debilitating side effects. A health care professional can administer MRIs and X-rays to help determine if a hip replacement has caused damage. Additionally, blood tests can help to monitor the presence of metal in the body.

View Sources

  1. “Hip Implant Recall: Stryker Orthopaedics Recalls Rejuvenate Modular Hip Systems.” Medical Devices & Surgical Technology Week 14 Oct. 2012: 268. Academic OneFile. Web. 1 May 2013.
  2. “Medical Devices.” U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 7 Jan 2013. Web. 1 May 2013. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm
  3. Meier, Barry. “Maker Aware of 40% Failure in Hip Implant.” New York Times 21 Jan 2013, A1. Web. 1 May 2013. http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0
  4. Reinberg, Steven. “FDA Probing Safety of Metal-on-Metal Hip Implants.” US News – Health. N.p., 27 Jun 2012. Web. 1 May 2013. http://health.usnews.com/health-news/news/articles/2012/06/27/fda-probing-safety-of-metal-on-metal-hip-implants?s_cid=rss:fda-probing-safety-of-metal-on-metal-hip-implants
  5. Toms, AP. “Early failure of a Birmingham resurfacing hip replacement with lymphoreticular spread of metal debris: pre-operative diagnosis with MR.” British Journal of Radiology. 82. (2009): e87-e91. Web. 1 May 2013. http://bjr.birjournals.org/content/82/977/e87.full.pdf
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