DePuy Orthopaedics, a division of Johnson & Johnson, designed its ASR XL Acetabular Total Hip Replacement System to accommodate younger patients with active lifestyles by offering more flexibility and a greater range of motion than other hip replacement devices.
The ASR hip implants were approved by the Food and Drug Administration (FDA) in 2005, under the agency's 510(k) clearance process, which allows medical devices that are “substantially similar” to currently-approved devices to be used in the United States without undergoing additional testing or clinical trials.
Initially quite popular, the ASR XL Acetabular Total Hip Replacement System was implanted in thousands of patients before significant flaws, side effects, and complications were widely reported. In 2010—five years after gaining FDA approval—DePuy Orthopedics issued a recall for the ASR hip implants, citing higher-than-usual failure rates. These failure rates range between 21 and 49 percent after just six years, according to information from the British Hip Society and the British Orthopaedic Association.
Flawed Design of the System
The ASR XL Acetabular Total Hip Replacement System is a large-diameter hip replacement device that's constructed from a single metal sheet. Although the device's metal-on-metal design was intended to offer increased stability and reduce the risk of dislocation, the flawed design actually contributed to the product's high failure rates. The metal-on-metal components grated with movement, releasing tiny metal shavings into the surrounding tissue. Additionally, the shallow ASR hip cup made it difficult for the device to implant properly, leading to a number of complications.
Side Effects Associated With the ASR Hip Implant
The faulty design of the ASR XL Acetabular Total Hip Replacement System can cause a wide range of serious side effects, including:
- Unexplained pain in the hip, thigh, or groin
- Pain and inflammation in the tissue surrounding the implant
- Pain when rising from a seated position
- Difficulty walking
- Localized or systemic metallosis (metal poisoning)
- Pseudotumors that form as a result of metallic debris
- Hip instability or dislocation
- Decreased mobility
- Muscle atrophy due to immobility
- Bone fracture near the implant site
Living with these side effects can be extremely difficult, particularly for someone who previously led an active lifestyle. This dramatic change in lifestyle and mobility can also lead to emotional side effects, such as anxiety and depression.
DePuy ASR Hip Implant Complications
DePuy ASR hip implants are also associated with a number of complications, including the loosening and dislocation of implant. However, the most serious complication related to the ASR XL Acetabular Total Hip Replacement System is the need for revision or reconstructive surgery to repair or replace the implant, or reconstruct bones and surrounding joints. These surgeries are often very costly, and much more invasive and painful than the initial hip replacement. Additionally, revision or reconstructive surgery patients often require multiple surgical procedures, as well as long and grueling rehabilitation periods. Additionally, these subsequent surgeries expose patients to side effects and risks, such as pain, inflammation, and infection.
Were You Harmed by DePuy ASR Hip Implants?
If you're a hip replacement patient who suffered from side effects and complications associated with the ASR hip implants, you need the representation of a seasoned and skilled personal injury attorney. The experienced legal team with McGartland Law Firm can help you explore your legal options and fight for compensation for your injuries. Our firm has 30 years of experience handling personal injury cases and accepts cases from all across the country. We also work on a contingency basis, so you don't pay a fee until your case is settled. Don't suffer in silence. Contact McGartland Law Firm today to schedule a free initial consultation by calling 866-957-5141 or completing our online contact form. We're eager to discuss your case and help you begin the healing process.