DePuy Hip Systems Recalled: What You Should Know
DePuy Orthopædics, Inc., recently recalled two hip aid systems citing high early failure rates. The business, a Johnson & Johnson Company division, sold about 93,000 units globally and found more people than expected suffered pain severe enough to require additional surgery.
The global recall comes in the wake of a recent Food and Drug Administration (FDA) warning letter issued to the company for selling hip and other joint products without the agency’s approval, based on its sale of other, unrelated products.
According to the Associated Press, this is the 11th Johnson & Johnson Company recall since September 2009.
The DePuy Units
The hip aid systems in question include the ASR LX Acetabular System and the ASR Hip Resurfacing System.
DePuy revealed an alarming statistics that showed approximately 13 percent of patients who had the ASR XL Acetabular System implants and 12 percent of patients who had the ASR Hip Resurfacing System implants required a second surgery after just five years of implantation. In the United Kingdom, statistics show 4.5 percent of these resurfacing devices require replacement within three years.
According to a DePuy spokeswoman, as a general rule, only five percent of hip implants should need replacing after five years.
As of late 2009, Johnson & Johnson Company no longer manufactures the systems.
DePuy advises individuals who were either ASR LX Acetabular System or ASR Hip Resurfacing System candidates to contact their doctors for additional testing.
Information for Hip Implant Replacement Patients
What if patients are not sure whether they were implanted with a recalled unit?
Patients should speak with the orthopedic surgeon who performed their surgeries in order to determine if they were implanted with the recalled units. A doctor may require additional X-rays or imaging scans to evaluate how the implant is performing. Blood tests may also be needed to help determine whether metal particles from the implants are causing problems.
Are there known symptoms affected patients may be experiencing?
Known symptoms may include:
- Pain: The components may not adhere to the bone, causing pain in the joint
- Difficulty walking
These symptoms may signal a loose implant. If left untreated, more significant complications could result such as:
- Hip bone fracture
- Loosening or dislocation of the implant
- Inflammatory reaction around the joint to a degree that causes a higher revision rate and makes revision surgery more difficult
- Increased levels of chromium in the blood
Not every patient may be experiencing pain or symptoms. Pseudo tumors may exist even in the absence of pain. Patients should consult with their physician and get tested immediately. Patients could make subsequent surgery more difficult if they wait for any pain to develop.
Was this preventable?
Some experts speculate that if the devices received proper testing prior to their use, the problems patients are experiencing could have been foreseen.
Is there any recourse for affected patients?
DePuy has agreed to cover “reasonable and customary costs of monitoring and treatment for services.” This includes additional surgery costs associated with the recall of ASR systems.
In Texas, the law allows injured parties to seek compensation for medical expenses, lost wages, physical impairment, mental anguish, and pain and suffering.
Contact an Attorney
Patients should speak with an experienced DePuy Hip Plan Recall attorney. A lawyer can offer invaluable information and discuss in further detail the options available.