Selection of a knee implant is one of the most important decisions that a surgeon makes before undertaking a knee replacement surgery. It is rare that a surgeon suggests an implant that is in recall list. However, as a recipient of an implant, you must be aware of its safety and its proven side-effects. A recalled implant is one that has been withdrawn from the market due to reasons such as design malfunction or poor outcomes, and may require an earlier revision surgery.
Common reasons for a revision surgery
We have spoken at length about knee replacement surgeries in our previous articles. When we learned about knee replacement implants, we also found out that they have limited lifespans; that is, they do not last forever and need to be replaced as and when necessary. The procedure or operation involving replacement of an implant is known as a revision surgery.
- Wear and tear or loosening of the implant.
- Infection at the implant site.
- Instability of the joint due to damaged ligaments.
- Reduced range of motion or persisting stiffness of the joint.
- Fractured bone around the implant.
- Long-term usage – most knee implants last for 15 to 20 years after which they need to be replaced.1
However, sometimes a faulty implant may be the cause for a revision surgery. In spite of the rigors of clinical trials and quality assessment procedures a medical device undergoes before being approved, certain defects may be discovered at a later stage.
Based on the recurrence of manufacturing defects and adverse events some implants need to be withdrawn from the market – this is known as implant recall.
Recalls of medical devices are initiated either if it has some defect or when it is likely to pose a risk to the health of patients or both.2
Why are some implants recalled?
The most common reason for knee replacement implant recall is reported adverse events linked to a manufacturing defect of an implant, such as:
- Premature implant failure or loosening.
- Implant fracture.
- Faulty implant design.
- Flawed implant tool.
- Labeling errors (for instance, wrong size).
- Improper assembly tools.
- Missing features in the implant.
- Metal debris in implanted anchors.
- Damaged implant components.
- Implant defect causing difficulties while assembly.
- Implant material with sub-optimal biocompatibility.
- Implant incompletely sealed, compromising sterility.
- Implants not meeting regulatory standards of the country.
- Complaints from healthcare professionals and patients of adverse effects related to an implant may make the regulatory authorities force a manufacturer to recall the implant.3
Which implants have been recalled?
According to data from the USFDA (United States Food and Drug Administration), 709 knee replacement implants have been recalled by six renowned manufacturers between February 2003 and May 2013, with DePuy and Zimmer scoring the highest among others. Although a majority of these decisions were made by the manufacturers rather than the FDA, these companies are obliged by law to report all recalls to the respective authorities.4
Below, we have enlisted some of the knee implants that have been recalled recently.
|Implants Recalled (Year)|
|DePuy Synthes (Johnson and Johnson) |
|Smith & Nephew |
|Implant Recalls Terminated|
|DePuy Synthes (Johnson and Johnson)|
|Smith & Nephew |
Kindly note that some implants mentioned in the recall list have been partially recalled, hence they can be available in certain countries.
A recall is terminated by a regulatory authority when all efforts have been made to correct a defective device to render it non-hazardous and when they can be proven to be in compliance with the recall guidelines of the authority.11
In April 2013, the USFDA recalled Stryker Orthopaedics ShapeMatch Cutting Guide due to its defects leading to serious hazards, such as fracture, instability, and the need for an earlier revision surgery.12
In 2008, LCS Knee Implant-Meniscal devices were recalled by its manufacturer (DePuy) for labeling errors related to dimensions.
The company was directed to recall PFC Sigma Knee Systems in 2010 due to lack of approval from the USFDA.
The USFDA uses a streamlined review for approval of medical devices (also known as 510(k) clearance process) which does not necessitate additional safety trials unless the knee implant model is significantly different from the ones that have been approved. The consequence of this policy is that many hazardous devices have found a leeway to enter that market without adequate vigilance.13
In 2011, the Institute of Medicine suggested that it should be necessary for manufacturers to prove that each medical device is safe and effective.14
A lawsuit was filed against Smith and Nephew Inc. in 2015, for marketing a defective implant (Genesis II total knee system). It was reported that the implant had been approved under 510(k) clearance process of the USFDA.15
In the same year, ConforMIS faced a lawsuit for failing to disclose flawed processes of manufacturing knee replacement implants.16
Zimmer Orthopedics was sued by a number of patients in the US over poorly designed knee implants. In 2015, Zimmer Inc. recalled all lots and sizes of Persona Knee Implants due to adverse effects, like joint damage, loosening of the implant requiring a revision surgery. Additionally, patients with a faulty implant could be eligible for compensation from the company, for revision surgery.17
Regulatory Authorities for Medical devices in India
Indian medical device market in 2012 was estimated to be $2.5 billion; 75 percent of which could be attributed to imported devices.18
In India, medical devices are regulated by The Central Drug Standards Control Organization (CDSCO) which is a part of the Ministry of Health and Family Welfare. In 2006, a bill was passed for the regulation of medical devices which was abolished in 2009 by the Council of States.
Presently, the governing regulation for medical devices in India is Drugs and Cosmetics Act, 1940 and Rules, 1945. In 2013, the Drugs and Cosmetics Amendment Bill was introduced which included regulatory guidelines for import, manufacture, sale, distribution, and export of medical devices.
Medical devices that have been approved in the United States and the European Union do not require an additional assessment to acquire approval to be marketed in India.
The Federation of Indian Chambers of Commerce and Industry (FICCI) has been collaborating with CDSCO and Indian medical regulators towards increasing access of medical devices to patients and streamlining their regulations. However, less expensive medical devices find a huge market in India and the fact that regulatory guidelines in the country are less stringent, makes matters worse.
Despite efforts of the Indian regulatory boards towards implementing a medical device vigilance system which is at par with the developed nations, further progress towards adverse event reporting of medical devices and global harmonization of regulations is required to ensure patient safety.19
What if my Knee Implant is Recalled?
Not all knee replacement implants come with a warranty. But if you have doubts about your knee implant or if the implant used in your knee has been recalled, first you must speak to your doctor regarding how you could prevent damage to your knee. Subsequently, you should contact your lawyer to find out your legal rights with respect to implant replacement or compensation.
Majority of patients who have had a defective implant choose litigation since the compensation facilitates payments of their medical bills and replacement of the failed knee implant. Besides, lawsuits may also speed up the process of recall of a defective implant by a manufacturer; this may help in preventing similar adverse events in future.
It is essential to note that an implant recall does not imply that it is sure to fail in all patients. It means that either the implant has a higher rate of revision surgery, that is, it may need a revision earlier than expected or it has a defect. A defect or an adverse effect of an implant may not be hazardous to all patients.
Yet, it is important to know the recall status of the implant chosen for you, before you undergo surgery. Such data is easily available in websites of regulatory bodies, such as USFDA and TGA.
Furthermore, if you already have an implant which has been recalled, you must make sure that it is closely monitored regularly. Your surgeon should be your best guide and his/her recommendations should be heeded to prevent and manage problems related to your knee implant.20
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