Hip Replacement Recalls
Several companies have recalled their hip replacement devices due to high failure rates that resulted in serious injuries for thousands of people. Most of the devices which have been subject to recall, have been metal-on-metal (MoM) construction which was intended to be longer lasting or more durable for younger and more active patients.
Examination of adverse event reports and other research revealed a failure rate of nearly 40-percent compared to the standard failure rate of less than 10 percent. In some cases, patients who received faulty devices began having complications within the first year after hip replacement surgery.
Hip Recall Process
Hip implant recalls may be conducted for reasons that range from packaging and labeling issues to much more severe concerns which may result in serious harm to a patient. In most cases, recalls are issued voluntarily by the company and announced by the FDA, but in more serious cases, the Agency may directly issue a mandatory recall.
Hip implant recalls which result in serious personal injury have largely involved MoM hip implants which allowed metal surfaces to grate against one another, releasing metal fragments and metal ions into joint spaces. Patients who experienced complications related to MoM hip implants were often required to undergo hip revision surgery to remove and replace a faulty device.
Hip Replacement Recalls
With the advancement of orthopedic technology, hip replacement devices have grown in popularity. Many of these devices feature state-of-the-art technology designed to help increase mobility for hip replacement patients. Newer designs were largely intended to improve mobility and be longer-lasting for a younger and more active patient.
Despite intentions to produce durable, high-mobility devices, a number of hip replacement recalls were required to be 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. Adverse event reports compiled by the U.S. Food and Drug Administration (FDA) and research groups has indicated that in some cases patients begin experiencing symptoms of failure within the first year after implantation of a device, while others show an overall failure rate of up to 40 percent.
Recalled Hip Implants include:
|DePuy Orthopedics||ASR Acetabular System
ASR Hip Resurfacing System
|Smith & Nephew||R3 Acetabular System
Birmingham Hip Resurfacing (BHR) System
|Stryker Corp||Rejuvenate Modular System
ABG II Modular System
Stryker Accolade TMZF
LFIT V40 Metal Femoral Head
|Zimmer Biomet||Durom Cup Metal Liner|
|Wright Medical||Conserve Plus
Profemur Z Hip Stem
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 most MoM hip replacement recalls in which 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.
Hip Implant Recall Lawsuits
Many of the recalled hip implant devices have resulted in thousands of hip replacement lawsuits being filed against manufacturers. All of the large orthopedics device companies have faced thousands of lawsuits for injuries caused by their devices. Some of these lawsuits have been settled but others remain in court systems and more may be expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.