What Is a Hip Replacement Recall?
A hip replacement recall is the removal of that hip replacement device from the market. A recall can also refer to a correction made to a device, but when most people think of a recall, they think of devices that have been removed from being sold due to a fault or other problem.
Who Can Issue a Recall?
A hip replacement recall can be issued by one of two organizations. The first is the company that manufactures it. The second is the FDA. Usually, a recall occurs because the company found fault with a device, its design, how it is stored, or the manufacturing process and voluntarily recalled it to address the issue. If the company fails to do so, however, the FDA can issue a recall that forces the company to comply.
What Are the Types of Recall?
There are three different types of recall. A class 3 recall is the least serious and indicates that the device violates FDA regulations but is unlikely to cause any harm. Class 2 recalls are for products that could cause illness, injury, or other harm, while Class 3 recalls are for devices that could cause serious harm or even death. The recalled hip replacements are all classified as Class 2 recalls.
Why Are Hip Replacement Devices Recalled?
Hip replacement recalls typically take place after many adverse events are reported by 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.
What Symptoms Have Patients Experienced From Recalled Hip Replacements?
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.
What Reasons for Recall Has the FDA Cited?
The FDA has listed the following as reasons for hip replacement recall:
- 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
What Is Hip Replacement Revision Surgery?
Many patients were forced to undergo revision surgery to correct the problems caused by 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 a 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 healthcare 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.
What Is the Hip Replacement Device 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.
Which Hip Replacement Devices Have Been Recalled?
The following hip replacement devices have been recalled by their manufacturers, according to the FDA.
Manufacturer | Device | Product recall | FDA link |
Zimmer | Metasul Durom acetabular component | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72743 |
Biomet | M2A Magnum Modular Head | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105901 |
DePuy | Pinnacle Hip Replacement System | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107791 |
DePuy | ASR 300 ACETABULAR CUP SYSTEM | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96129 |
DePuy | ASR Acetabular Cups 70
ASR XL Acetabular Cup System |
Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96142 |
Stryker | Rejuvenate Modular Stems | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110699 |
Stryker | ABG II Modular Hip Stem | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110697 |
Stryker | Accolade TMZF Plus Hip Stem | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99392 |
Stryker | LFIT V40 Metal Femoral Head | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149782 |
Smith & Nephew | R3 Acetabular Liner | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94544 |
Smith & Nephew | R3 No Hole Hemispherical Stiktite Coated Shell | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=181431 |
Smith & Nephew | R3 Three Hole Hemispherical Stiktite Coated Shell | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=181433 |
Smith & Nephew | R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=181432 |
Smith & Nephew | R3 Multi-Hole HA Coated Hemispherical Stiktite Coated Shell | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=181436 |
Smith & Nephew | XLPE Acetabular Liner | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118701 |
Smith & Nephew | Modular REDAPT (TM) Hip Systems | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151502 |
Wright / MicroPort | Profemur Titanium and Cobalt Chrome modular necks | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=183091 |
Wright / MicroPort | Profemur Neck Long Titanium | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=182849 |
Wright / MicroPort | Profemur Plus CoCR Modular Neck | Manufacturer initiated | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139368 |
There are hundreds of hip implant devices on the market, many of which function as intended. In general, it is up to the orthopedic surgeon to choose the correct implant for a particular patient. The surgeon makes his choice based on the patient’s physiology. He or she will also evaluate the aspects of the available implants.
When a manufacturer has made claims concerning safety and performance that are misleading or turn out to be incorrect, the patient pays the price with pain and suffering. In most cases, this is directly related to the device’s performance and the manufacturer’s practices.
Why Were Zimmer Hip Replacements Recalled?
Zimmer manufactures a number of modular hip implant systems, one of which has received multiple complaints of an improper seal of the implant due to a plasma coating that is used in place of the cement normally used for other implants. The moving of the cup has caused a requirement for numerous revision surgeries.
Zimmer introduced the implant device in 2006 and by 2007, reports began to surface of failure within one year after implant. The Durom Cup was briefly recalled in 2008 after Zimmer claimed that any failures were due to improper surgeries.
The implant device was re-introduced with labeling additions and a new physician training program. Thousands of US patients have received the implant and Zimmer has faced multiple lawsuits. The company set aside $69 million but has already paid $400 million and expects to pay at least $200 million more. Zimmer’s own estimates show that up to 5.7 percent of the implants will require revision surgery.
Why Were Biomet Hip Replacements Recalled?
Biomet manufactures several hip devices, including MoM hip implants. They have claimed long-life span as a primary benefit of their systems but by 2011, multiple complaints of failure had been reported to the FDA, all of which occurred within the first two years after implant.
Biomet is battling numerous lawsuits related to the M2a implant and also faced claims by the Securities and Exchange Commission (SEC) regarding the Foreign Corrupt Practices Act.
Biomet was found guilty of bribing doctors in China, Brazil, and Argentina to use its hip replacement devices between 2000 and 2008. To settle the claims, Biomet paid $22.9 million in 2012. Biomet federal lawsuits were brought together in MDL and have been settled for $56 million, however, additional cases have been filed. Zimmer acquired Biomet in 2015.
Why Were DePuy Hip Replacements Recalled?
A division of Johnson & Johnson, the largest medical and pharmaceutical products company in the world, developed three hip replacement systems, each showing a high failure rate. The device failure of each system is primarily due to its metal-on-metal construction.
The two ASR systems were recalled in 2010 but court documents from 2013 show that DePuy expected up to 40 percent of the devices to fail within five years. DePuy has agreed to settle 7,500 lawsuits for a total of $2.5 billion and has faced nearly 5,000 more.
Why Were Stryker Hip Replacements Recalled?
Two of the hip implant products have resulted in complications including both implant loosening and metallosis.
- Rejuvenate Hip System
- ABG II modular-neck hip stem
- LFIT Anatomic V40 Femoral Head
- Accolade TMZF Plus Hip Stem
In 2012, both of the systems were recalled a few months after Stryker began issuing warnings to physicians about metallosis, necrosis, and other complications that would result in revision surgery. The first lawsuit was filed in New Jersey in 2012 and federal cases were consolidated into multidistrict legislation (MDL). Many more lawsuits have followed and more are expected.
Why Were Smith & Nephew Hip Replacements Recalled?
Smith & Nephew introduced a metal-lined modular hip replacement device in 2012 which was the first of its kind. Nearly 8 thousand patients have received the device and may be at risk for revision surgery which has shown a failure rate of over 6 percent.
- R3 Acetabular Liner
- R3 No Hole Hemispherical Stiktite Coated Shell
- R3 3 Hole Hemispherical Stiktite Coated Shell
- R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell
- R3 Multi-Hole HA Coated Hemispherical Stiktite Coated Shell
- XLPE Acetabular Liner
- Modular REDAPT Hip System
The device was recalled in 2013 due to poor performance. The device has been reintroduced but now contains a plastic cup with a proprietary metal alloy or ceramic head.
The device originally contained metal-on-metal which has resulted in severe effects for many MoM implants and the Smith & Nephew device has shown an alarming failure rate. Smith & Nephew has been the subject of multiple lawsuits which are still in process.
Why Were Wright Medical Technology Inc. Hip Replacements Recalled?
Wright Medical Technology has manufactured hip implant devices that are similar to DePuy products subject to investigations and lawsuits including MoM systems. Despite complaints of failure, the devices have not yet been recalled and over 10 thousand have been implanted in patients in the US.
Wright faces numerous personal injury lawsuits from patients across the US for injuries including metallosis, infections, and necrosis of bone and tissue. The company also paid $7.9 million to settle allegations of bribing surgeons to use their devices.
Wright devices may require revision surgery in over 8 percent of patients within the first five years of implant. Additional lawsuits are expected regarding device failure.
Are People Filing Hip Replacement 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.
Sources
- Affairs, O. of R. (n.d.). Recalls background and definitions. U.S. Food and Drug Administration. Retrieved June 24, 2022, from https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
- Class 1 device recall Profemur Neck Long Titanium. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=182849
- Class 1 device recall Profemur Plus Cocr Modular Neck PHAC1254. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139368
- Class 2 device recall ABG II modular hip stem. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110697
- Class 2 device recall accolade TMZF Plus Hip Stem. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99392
- Class 2 device recall DEPUY ASR 300 acetabular cup system. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96129
- Class 2 device recall DEPUY ASR XL acetabular cup system. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96142
- Class 2 device recall Durom Cup. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72743
- Class 2 device Recall Modular REDAPT(TM) hip systems. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151502
- Class 2 device recall Pinnacle. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107791
- Class 2 device recall Profemur. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=183091
- Class 2 device recall R3 ™ XLPE acetabular LINER UHMWPE, 20O overhang, 36 mm ID, 62 mm OD. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118701
- Class 2 device recall R3 constrained acetabular liner. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94544
- Class 2 device recall rejuvenate modular stems. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110699
- Class 2 device recall Selex M2A Magnum modular head, 40 mm. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105901
- Class 2 device recall smith&hephew R3 multi hole ha coated hemispherical stiktite coated shell. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=181436
- Class 2 device recall smith&hephew R3 no hole hemispherical STIKTITE coated shell. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=181431
- Class 2 device recall smith&hephew R3 no hole hemispherical STIKTITE coated shell. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=181431
- Class 2 device recall smith&hephew R3 three hole hemispherical STIKTITE coated shell. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=181433
- Class 2 device recall smith&hephew R3 zero hole ha coated hemispherical stiktite coated shell. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=181432
- Class 2 device recall Stryker LFIT anatomic V40 femoral head. accessdata.fda.gov. (n.d.). Retrieved June 24, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149782
- FDA. (n.d.). Information for Orthopaedic Surgeons. U.S. Food and Drug Administration. Retrieved June 24, 2022, from https://www.fda.gov/medical-devices/metal-metal-hip-implants/information-orthopaedic-surgeons
- FDA. (n.d.). What is a medical device recall? U.S. Food and Drug Administration. Retrieved June 24, 2022, from https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
- Meier, B. (2013, January 22). Maker aware of 40% failure in hip implant. The New York Times. Retrieved June 24, 2022, from https://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0