How Do I Know If I Have a Recalled Hip?

Searcy Denney Scarola Barnhart & Shipley
Contact

As a medical device lawyer for more than 20 years, I have received so many calls from patients who are concerned that they have a recalled hip implant in their body. Often, their first notice of a potential problem with their hip replacement device is when they hear something on TV, often a lawyer advertisement, that mentions a recall or safety concerns over a particular hip implant model. In addition to having concerns about their health due to having a potentially defective device in their body, many of these patients are also angry that their surgeon or the medical device manufacturer did not notify them directly of potential safety issues, ask them to return to the office for closer monitoring for potential problems, offer financial assistance for follow up evaluations, etc.

So, perhaps the best place to start is with a question. Who has an obligation to notify patients of potential safety issues with a hip implant? The answer, unfortunately, is perhaps no one, especially for a device not yet formally recalled.

Why Aren’t Patients Tracked?

Sadly, in the United States, we do not have formal joint registry tracking the performance of hip implants placed in patients. These joint registries are common in other countries and provide some of the best data on patient outcomes, comparison of performance of various manufacturer’s models, implant life-expectancy well-performing as well as poor-performing hip implants. In fact, many of the safety signals and scientific evidence that led to hip implant recalls or widespread defective product lawsuits in the United States emanated from national joint registries and hip implant safety surveillance in Australia and the United Kingdom.

For example, the DePuy ASR hip implant was recalled in the United States in August of 2010 only after there was an uptick noted in the foreign registries for patients undergoing revision surgeries within several years of implantation of this metal-on-metal hip implant product due to the presence of elevated levels of cobalt and chromium, metallosis, osteolysis, soft tissue and bone necrosis, and pseudotumor formation. The American Academy of Orthopaedic Surgeons (AAOS) started a national registry program in 2011 which now includes more than 30,000 patients, which is a step in the right direction but far short of what patients in the United States deserve.

For years, the medical device industry has fought the implementation of a national registry in the United States, arguing that the implementation of such a system would be very costly. Yes, there is a cost associated with maintaining a national device registry (or at least a registry maintained by the implant manufacturer), but this cost is not too much for other manufacturers, such as the automotive industry, that can easily send out recall notices by tracking VIN numbers on the vehicles that it sells.

Solutions From Other Industries

It is sad that more thought and resources are put into alerting consumers of a defective wiper blade than in informing patients of the need for prompt medical evaluations due to their implantation with a dangerous medical device. The hip implant manufacturers also argue that a national database with hip implant details is only possible in other countries due to universal healthcare or socialized medicine. The other reality is that a national database would allow surgeons and patients to compare the performance of similar hip implant models marketed by the hip implant manufacturers, and that is something that is frightening to the manufacturers as they would prefer to conduct and publish their own, tightly-controlled studies that would have a direct impact on their marketing and sales performance.

Some manufacturers do attempt to keep a record of patient implant information so that they technically have the ability to notify patients when there are problems, but other device manufacturers make the conscious decision to keep no records that would enable them to contact patients if there was a problem with one of their medical devices (and are within their legal rights to do so).

If there is a recall of a product or a serious safety issue that the hip implant manufacturer has publicly conceded, then that information is generally passed to the orthopedic surgeons through direct communication from the medical device manufacturer. Most surgeons will then share that important safety information with their patients, but only those who are visiting the office for follow up visits or those who are seeking medical evaluations for problems associated with the implants. The biggest challenge with hip implant patients is that most stop seeing their orthopedic surgeon not long after the initial surgery, even though they should be following up on an annual basis (especially in light of the number of modular and metal-on-metal hip implants that have been the subject of recalls or safety issues over the past 5 to 10 years).

Surgeons Can’t Do It All

Very few surgeons will proactively reach out to patients with whom they are no longer treating to alert them to a recalled hip, and it is likely that the surgeon does not have a master record of all of the devices implanted (such that individual patient charts would need to be pulled and reviewed in hopes of identifying the hip implants placed in the patients). Further, there are often safety concerns with a hip implant that does not lead to a formal FDA recall of the device, and those patients are unlikely to obtain information from the manufacturer (who denies that there is a problem with the product).

When the Stryker ABGII and Rejuvenate modular hip implants were recalled in July of 2012, many patients received direct communication from their orthopedic surgeons about the recall as well as the Broadspire program to reimburse out-of-pocket expenses to surgeons and patients for evaluations and revision surgeries required to remove the femoral stem of the hip implant which was prone to corrosion and galvanization.

Since the failure of the recalled Stryker Rejuvenate and ABGII hip implant occurred within months or only a few years of implantation, many of the patients were still seeing their surgeons on a regular basis, such that notification was possible. Unfortunately, some surgeons, however, chose for whatever reason not to proactively notify their patients that they had been implanted with a recalled Stryker hip implant. Many of those patients may have suffered more bone and tissue damage as a result of the delay in removing the corroded femoral stem.

Tips If You’re Concerned About A Recalled Hip Implant

Here are some tips for patients who are concerned that they have been implanted with a failed, defective, or recalled hip implant:

  • Return to see your orthopedic surgeon on an annual basis and notify your surgeon of any changes in your contact information. Ask your surgeon for details about the hip implant that was implanted into your body and follow up annually to see if additional information has been discovered relating to the performance of the device or any safety issues.
  • Request a copy of the operative report for your original surgery including the product identification stickers. Unfortunately, many surgeons do not have the stickers in their patient chart, but they should be included in the hospital chart. Often the stickers are peeled off of the boxes that include the hip implant components during the surgery and attached to the handwritten notes kept during the surgery by a member of surgical team, usually the scrub nurse. When we request medical records from a hospital in an effort to obtain product identification information, we specifically request an abstract from the hospital that includes the operative report as well as the product identification stickers. Some hospitals are now keeping electronic records for all of their surgical procedures and will discard the stickers but type in the brand name, model number, lot number, and other pertinent information from the stickers into the electronic surgical notes.
  • Set up a Google alert for the type of hip implant that you received with at least the name of the manufacturer and model number, so that you can be notified via email if there is anything published on the internet with regard to your particular device. Although patients generally believe that all devices that are the subject of lawsuits are recalled devices, that is rarely the case, so avoid using the word “recall” in your alerts, as you may miss out on important safety information. It is unlikely that a recall notice is going to list the lot number for a particular recalled device either, so avoid including those in your alert request.
  • If a device is recalled, there will be safety information published on the manufacturer’s web site as well as the FDA web site. Generally, these sites have a search function that will allow you to easily locate important safety information about a particular device. Unfortunately, however, manufacturers may issue a “field safety notice” or “hazard alert” directly to physicians for safety issues that they contend do not rise to the level of a formal recall, and these notices are often not readily available online or provided to patients.
  • Be wary of lawyer web sites. There are lots of them out there. Some provide good information to patients about potential risks, while others are focused on attracting new clients. That being said, when there is a potential safety issue with a medical device, these sites may include more information than any other source.
  • The FDA has a web site (www.fda.gov) with lots of information about pharmaceuticals, medical devices, and other types of products. It is searchable and will include warning labels, patient information materials, some adverse event reports, and recall notices.

Written by:

Searcy Denney Scarola Barnhart & Shipley
Contact
more
less

Searcy Denney Scarola Barnhart & Shipley on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.