Specializing in hip and knee implants, the Johnson & Johnson subsidiary company DePuy calls itself a global leader in providing healthcare solutions in orthopedics. Unfortunately, 93,000 of their hip replacement systems have been recalled after failing prematurely, causing dangerous and painful side effects in patients, including tissue damage and the need for further surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Johnson & Johnson hip replacement induced injury cases in all 50 states. If you or somebody you know has been injured by a Johnson & Johnson hip replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
J&J Hip Implant Linked to 37% Five-year Failure Rate
Documents unsealed in state court in January 2013 indicate that DePuy knew about problems with the ASR in 2008, but waited two years to issue a recall. A company analysis in 2011 linked the ASR to a 37% five-year failure rate, which is significantly higher than the industry’s “acceptable” 5% five-year failure rate. Click here to read more.
Johnson & Johnson (DePuy) Hip Replacements: An Overview
Hip replacement surgery is usually conducted in order to completely replace the hip joint in patients with severe arthritis or to fix severe joint damage as a result of a hip fracture. The Anticular Surface Replacement (ASR) XL Acetabular System and ASR Hip Resurfacing System were two hip replacement systems developed by Depuy. Made from metal alone, they were believed to last longer than traditional metal and plastic systems. Additionally, they were considered beneficial because patients were expected to experience less tissue and bone loss during surgery.
To date, DePuy’s ASR systems have been implanted in approximately 40,000 patients.
Unfortunately, on August 24, 2010, both the ASR XL Acetabular System and the ASR Hip Resurfacing Systems were voluntarily recalled. The metal fittings in both of the systems were found to wear away, releasing metal debris into the body. As a result, patients experienced several severe and painful side effects, including the need for a second surgery, increased levels of cobalt and chromium in the blood, bone fracture, infection and soft-tissue damage.
Due to the severity of these symptoms, Johnson and Johnson hip replacement patients may want to contact a Johnson & Johnson hip replacement lawyer with The Schmidt Firm, PLLC to discuss the potential of a Johnson and Johnson hip replacement lawsuit.
Johnson & Johnson Hip Replacement Side Effects and Symptoms
The following side effects and symptoms are related to a failing hip replacement surgery:
- Loosening and misalignment of the hip replacement component
- Bone fracture
- Metal sensitivity
- Soft-tissue damage
- Debris inside the body
- Difficulty walking
- Blood poisoning
- Presence of toxic metals in the blood
Johnson and Johnson (DePuy) Hip Replacement Study
In a study conducted by the National Joint Registry of England and Wales, 1 in 8 patients who received an ASR implant required a second replacement operation — a revision surgery. Of the patients who received the ASR XL Acetabular System during surgery, 13 percent needed a second operation. Of the patients who received the ASR Hip Resurfacing System, 12 percent required a revision surgery.
The study found that the those at the highest risk were patients who received a femoral head size smaller than 55 and females.
FDA Approval Guidelines for ASR Hip Replacements
While all all medical devices must be approved and classified by the FDA before they are allowed to enter the U.S. market, the guidelines for joint replacement systems are less strict than the guidelines placed on other products in the marketplace — such as medications and drugs.
Instead, a joint replacement system such as the ASR Hip Replacement may be approved by the FDA without ever being tested in patients. Any new product that is similar to an already commercially available product may be pre-approved under the 510(k) model. It costs much less for manufacturers and takes a fraction of the time to go through approval.
The ASR XL Acetabular System was pre-approved, as it resembled previous systems already on the market. This means that it never underwent any testing before being sold. If it had been tested, it’s possible that the FDA would have been aware of the adverse side effects of the ASR systems before they were implanted in patients worldwide. This pre-testing could have saved patients needless suffering and pain.
As a hint towards a possible change in the winds, the FDA recommended substantial changes in the 510(k) model on August 4, 2010, in hopes of revamping the system and making it safer for customers.
Johnson and Johnson (DePuy) Knee Recalls
Hip replacement systems are not the only DePuy products proven to be defective.
Unfortunately, there have been cases in the past of DePuy knee systems also being recalled.
In 2001, British government officials recalled the manufacturer’s Hylamer liners because they were found to have been sterilized with gamma radiation. The gamma radiation made the implants brittle, and caused them to break easily. Patients who received these liners showed a 67.6 percent failure rate, which is 13 times higher than the norm.
In 2008, DePuy recalled its LCS Knee – Orthopedic Knee Implant, Meniscal Bearing Insert. The product was not labeled correctly and was mis-etched for size.
Finally, on August 19, 2010, The FDA sent a letter of warning to Johnson and Johnson directing them to stop illegally marketing their Corail Hip Systems and their TruMatch Personalized Solutions Systems. According to the FDA, both systems were marketed in unapproved ways by DePuy. Statements about the coating in the Corail Hip implant, including claims that it aided in post-surgical healing and assisted in keeping the device in place, were not included in the original product approval by the FDA.
Furthermore, the TruMatch Personalized Solutions System was never approved by the FDA. The system used a special form of technology to produce a 3 dimensional model of the patient’s knee, which the surgeon could use to implant a better device.
Do I Have a Johnson & Johnson Hip Replacement Lawsuit?
The Schmidt Firm, PLLC is currently accepting Johnson & Johnson Hip induced injury cases in all 50 states. If you or somebody you know has been injured by Johnson & Johnson Hip, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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