Patient sues Wright over defective ProFemur total hip system

Dale Purcell, a plaintiff from Phoenix, AZ has filed a lawsuit in the US District Court against Wright Medical Technology after needing emergency surgery following a sudden catastrophic fracture of the titanium modular neck of his Wright ProFemur total hip system in July 2011. Purcell had the device implanted in June 2005.

According to the complaint, the titanium modular neck used in the plaintiff fractured and broke very near the femoral stem, leaving a broken portion of the titanium neck wedged inside the stem. The fracture of the modular neck adapter caused failure of the system, requiring corrective surgery, and made it extremely difficult to extract the fragment. The complaint points out that “Studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter…are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium”.

A 2009 report by the Australian Orthopaedic Association claims to show that the Wright ProFemur Z femoral stem had a high failure rate, requiring approximately 11.2 per cent of all patients receiving the implant to need revision surgery. Wright is alleged to have changed the material in the ProFemur hip system modular necks in 2009 from titanium to cobalt chrome alloy, but took “no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters”.

Article source: Orthopaedic Business News kindly provided by Sophie Bracken, Espicom’s medical newsletters editor.

Hi and welcome back to the Medical Technology Blog, and today’s post come from Espicom’s excellent news publication, Orthopaedic Business News, please read on…

Like the National Joint Registry of England & Wales before it, the American Academy of Orthopaedic Surgeons (AAOS) has been busy with the task of establishing the American Joint Replacement Registry (AJRR) – a project designed to collect data on all primary and revision total joint replacement procedures in the US. The registry’s mission is to improve patient safety and quality of care, as well as reducing the associated cost. With that mission in mind, the AJRR has recently completed its pilot programme of data collection.

Dr John Callahan, Vice President of AAOS and team leader of the AJRR project, said that past medical registries have been shown to help reduce the cost of medicine and, in particular, the burden of joint replacement. Callahan believes that decreasing revision surgeries by half would save millions anually for healthcare payers as well as for the US government. “Because of this, US Congress is interested in including registries in healthcare reform. The AJRR will be able to provide information in a timely manner, where it can be analysed by orthopaedic surgeons”, he said.

Short-term, the registry aims to establish an infrastructure and a uniform system for the collection of information and monitoring outcomes of total joint replacement in the US, as well as identify patients who may need follow-up evaluation, thereby increasing patient safety. Long-term, the registry’s goals are to create a real-time feedback mechanism in order to detect “sub-optimal” performance, and establish a uniform system that can be used to expand understanding of total joint replacement for research to improve patient care.

AAOS statistics show that in 2006 alone, more than one million hip and knee replacement took place in the US. Of these, around 7.5 per cent were revision surgeries, resulting in 77,000 procedures, at a cost of over US$3.2 billion. The AAOS has projected that the AJRR will reduce healthcare costs by around US$1.3 billion over the next 20 years. The AAOS believes that even a 2 per cent decrease in revision rates could potentially save US$65.2 million a year. Similar registries in Sweden, England & Wales, Canada and Australia have seen up to a 10 per cent reduction in revision rates as a direct result of their own registries.

However, the registry is not all about saving cash. Explaining the registries main aims and focus points, Dr David Lewallen, Chair of the AJRR Board of Directors, said there is a national interest in registries, particularly how patients will benefit. In the past, national data collection of hip and knee implants has helped to improve care by allowing surgeons, device manufacturers and hospitals to better understand what aspects of joint replacement is successful, and what needs to be improved. Lewallen said that the AJRR will enable surgeons, hospitals and device manufacturers to review their own data and compare their performance with similar institutions, in order to understand where opportunities for improvement may exist. The registry will also be a resource for patients, who will be able to contact the registry to find out what methods and devices were used at the time of their surgery.

The AJRR aims to gather data on all replacement and revision surgeries, including younger patients who are not recipients of Medicare – with the ultimate goal of achieving 90 per cent participation. The AJRR was set up in June 2009, and enrolment began in 2010. Participating hospitals have been submitting data for only a few months, but already information on over 3,600 primary and revision replacements has been assembled from eight different reporting sites, marking the culmination of the pilot stage.

Following an updated report on the pilot project, covering lessons learned and data analysis, the AJRR Board of Directors have begun formulating strategies for outreach recruitment, expanding resources and efficient data collection methods as the registry moves to full production. The AJRR’s timeline for 90 per cent participation in the registry is for October 2013.

At the moment, the AJRR is focused on collecting so-called “level-one” data, which includes a number of core data elements, such as patient, surgeon, procedure and hospital data. Each patient, surgeon and hospital has a unique identifier, which enables index procedures to be linked to subsequent events, permits patients to access their own information, allows data to be linked to other databases and helps maintain confidentiality.

Level-two data include variables that could enhance the value of the data analysis and allow risk adjustment, such as the patient’s body mass index and any comorbidities, as well as process of care data such as antibiotic prophylaxis. Level-three data will focus on outcomes and patient satisfaction, while level-four data (such as radiographs) provide more in-depth analysis of why and how implants or procedures fail.

Lweallen said the next step of the AJRR is to recruit a Medical Director to supervise operations. The registry is also moving toward implementing systems that will enable a wide range of hospitals and systems to submit data.

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Today on the Medical Technology Blog we have some Orthopaedic Business News, please read on…

Wright Medical Technology’s President and CEO, Gary D Henley, has resigned from his positions and as a Director of the company. Henley had served as President and CEO and as a Director since 2006. He tendered his resignation prior to a Board meeting called to discuss management’s oversight of the company’s ongoing compliance programme. The Board accepted Henley’s resignation but considered it to be without “good reason” under the terms of his employment agreement, and he therefore is not entitled to severance. In the interim, the Board of Directors has appointed its current Chairman, David D Stevens, as President and CEO with immediate effect. Stevens remains Chairman of the Board.

In addition, the Board has terminated Frank S Bono’s employment, the company’s Senior Vice President and CTO, for allegedly failing to exhibit appropriate regard for the company’s ongoing compliance programme. The company stated that these leadership changes are not related to its operational performance, financial condition or financial reporting. Wright’s Board of Directors has formed a committee comprised of Directors Stevens, Robert J Quillinan, Lawrence W Hamilton and John L Miclot to undertake a search for a permanent CEO. Stevens has asked not to be considered for the permanent CEO position but will serve as interim CEO until the selection process is completed.

In keeping with other orthopaedic companies at the time, Wright signed a deferred prosecution agreement (DPA) with the US Attorney’s Office (USAO) for the District of New Jersey and a civil settlement agreement (CSA) in September 2009. These agreements resolved a USAO investigation into Wright’s consulting arrangements with orthopaedic surgeons relating to its hip and knee products in the US.

Under the DPA, the USAO agreed not to prosecute the company in connection with the matter if Wright satisfies its obligations during the 12-month term of the DPA.  As part of the CSA, the company also shelled out  US$7.9 million to settle civil and administrative claims and entered into a five-year corporate integrity agreement with the Office of the Inspector General of the US Department of Health and Human Services. An independent monitor was also appointed to review and evaluate the company’s compliance with its obligations. So the departure of its top man, and without a pay-off, will come as a worry for Wright’s shareholders, who must be thinking what is going on at the fast growing business. Certainly the departure will raise eyebrows with the USAO and other regulatory bodies amidst concerns that the company may have failed to stick to its commitments.

It’s not the first time the company’s management abilities has been questioned either. The company made a complete mess over its planned closure of a plant in Toulon, France, in November 2010. After failing to convince the court that there was an economic justification for the dismissal of its employees, Wright was forced to pay at least US$.4.5 million to settle that dispute. Could this collectively throw open the door to opportunistic predators interested in the company’s extremity, hip and knee repair and reconstruction assets? Certainly, the company’s management team has never appeared to be so weak and out of its depth.