A medical device recall is an action taken by a manufacturer to address a product that violates regulatory laws or poses a health risk to patients. For hip replacement implants, a recall typically signals a need for intensified patient monitoring or a warning regarding a higher-than-expected rate of premature failure. This notification alerts patients and surgeons that a specific implant may present an unacceptable risk compared to its intended benefit. Understanding the specific brand and model of an implanted device is the first step toward determining any necessary follow-up care.
Specific Brands and Models Subject to Recall
The majority of significant hip replacement recalls have historically centered on “metal-on-metal” designs, where both the ball and socket components are made of metal. Although marketed for durability, these systems demonstrated a high failure rate in practice.
One of the largest recalls involved the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System, voluntarily recalled by DePuy Orthopaedics in August 2010. Registry data showed a high rate of revision surgery was required for these devices within five years of implantation, far exceeding the expected lifespan.
Stryker Corporation issued a voluntary recall in July 2012 for its Rejuvenate Modular and ABG II Modular-Neck Stem systems. These devices were recalled due to concerns over fretting and corrosion at the modular neck junction, which could lead to adverse local tissue reactions.
A later recall by Stryker in 2016 also affected certain sizes of the LFIT Anatomic V40 Femoral Heads due to high rates of taper lock failure. Other manufacturers have also issued recalls for specific components, including Smith & Nephew for the metal liner of the R3 Acetabular System and Wright Medical Technology for the Conserve Plus and Profemur Z Hip Stem devices.
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), classify recalls based on the potential health hazard. A Class I recall is the most serious, indicating a high probability of serious adverse health consequences or death. Class II recalls involve devices that may cause temporary or reversible health problems, and Class III relates to products that violate FDA law but are unlikely to cause health issues. The definitive source of information regarding a specific implant remains the orthopedic surgeon, who can confirm the manufacturer, model, and lot number.
Engineering Failures Leading to Recalls
Recalls are driven by material and mechanical failures that manifest prematurely in the patient’s body. The primary technical issue in many metal-on-metal hip recalls is excessive wear between the articulating surfaces. This wear generates microscopic particles of cobalt and chromium metals, which are shed into the joint space and bloodstream, a condition known as metallosis.
Another significant failure mechanism is fretting and corrosion, often occurring at the junction where two different components of the implant meet in modular designs. This corrosion leads to the release of metallic debris, causing inflammation, tissue damage (necrosis), and the formation of fluid collections called pseudotumors around the hip joint. Design flaws or material fatigue can also lead to component loosening or fracture, necessitating complex revision surgery.
Immediate Actions for Patients
A patient who learns they have a potentially recalled hip implant should contact their orthopedic surgeon immediately to confirm the device’s status and discuss a monitoring plan. Locating the implant identification card or surgical records is the first step, as this documentation contains the specific manufacturer, model, and lot number required for confirmation. Patients should not demand immediate removal of the device, as revision surgery carries risks and is only recommended when clinically necessary.
Follow-up monitoring often involves specialized diagnostic procedures beyond a standard X-ray. These typically include whole blood tests to measure cobalt and chromium ion levels, which mark device wear and metallosis. If metal ion levels are elevated, the surgeon may recommend cross-sectional imaging, such as Magnetic Resonance Imaging (MRI) or ultrasound. This imaging assesses soft tissues around the joint for inflammation, fluid collection, or pseudotumor formation, indicating an adverse local tissue reaction (ALTR).
Recognizing Signs of Device Complication
Patients with any hip replacement, especially those with recalled models, should be vigilant for specific physical symptoms that may signal device failure. The most common sign is the onset of new or increasing pain in the groin, hip, or leg that was not present after the initial recovery. This pain may be accompanied by unexplained swelling or warmth around the joint.
Mechanical complications can present as difficulty walking, an inability to bear weight, or a noticeable change in gait. Some patients report audible signs such as clicking, popping, or grinding sounds coming from the joint during movement. If the device is metal-on-metal, patients should also monitor for systemic symptoms related to metallosis, including skin rash, fatigue, or cognitive changes.