More than 50,000 units of the DePuy Synthes Radial Head Prosthesis System were recalled from the United States after patients reported that the elbow implant system would loosen and cause complications, including severe pain and revision surgery.
Now, lawyers are expecting a wave of DePuy Lawsuits over claims that the medical device company knew of the risks associated with the elbow implant and failed to warn the public.
The Radial Head Prosthesis is just the latest joint implant device from DePuy to be recalled over defects that have caused injuries. Learn more about what led to the recall and how a DePuy lawsuit can help hold DePuy accountable for its actions.
About the DePuy Synthes Radial Head Prosthesis System
In December 2013, DePuy Synthes Trauma — a division of DePuy Orthopaedics — announced that it was launching a new technology called the Radial Head Prosthesis System.
“This system is a comprehensive solution for the radial head replacement that permits the surgeon to choose whether a long or short stem is best for the proximal radius,” Harry Hoyen, a doctor and consultant to DePuy Synthes Trauma, said in the press release1.
The purpose of the system is to restore joint function by replacing the radial head of the elbow. The radial head is at the top of the radius bone of the arm just below the elbow2.
The system is designed to work as a replacement for those with degenerative or post-traumatic disabilities as well as those who have suffered radial head fractures that are beyond repair. The elbow implant was also indicated for revision, after failed radial head arthroplasty.
The elbow replacement surgery, or elbow transplant, involves implanting a head and a stem into the patient’s elbow. The modularity of the system allows the surgeon to choose from 24 heads and ten stems to achieve maximum fit and stability. During the surgery, the stem is fitted so that the bone grows around the device to keep it secure.
However, not long after its debut, multiple reports of elbow replacement surgery complications surfaced. Patients started reporting elbow implant loosening.
DePuy Elbow Implant Recall
Between 2014 and 2016, the U.S. Food and Drug Administration received dozens of reports that the DePuy Synthes Radial Head Prosthesis System had loosened in patients and required revision surgery to repair. Not only is revision surgery costly but it puts the patient at a higher risk of infection and pain.
While elbow implant loosening is a problem in itself, it can also lead to other complications. For example, loosening of the elbow implant could cause osteolysis, an issue in which the body attacks the bone cells and causes bones to become weaker.
As a result of the reports, DePuy issued a recall of all 50,311 units of the DePuy Synthes Radial Head Prosthesis System in late 2016. Although only the stem was prone to loosening, DePuy decided to recall the whole device.
“Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to characterize these factors fully,” the subsidiary of Johnson & Johnson wrote in the notification to surgeons3. “Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market.”
DePuy warned that potential problems with their Synthes Reaid Head replacement could include poor joint mechanics, osteolysis, bone fracture, pain, soft tissue damage, and elbow implant loosening.
Healthcare practitioners who had implanted patients with the devices were told they should follow patients in the usual manner
DePuy Elbow Implant Approved Through Expedited Process
Despite being approved by the FDA for use in the United States, DePuy was not required to undergo rigorous clinical trials and to test to prove the safety and efficacy of the elbow replacement. That’s because the Synthes Radial Head replacement system went through the agency’s 510(k) approval process.
To be approved through 510(k), the maker must demonstrate that a device is “substantially equivalent” to another device already approved on the market.
“Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable,” according to the FDA4.
In the 2011 510(k) application for the Synthes Radial Head Prosthesis System, the maker argued that it was similar to several other devices already on the market.
“The proposed Synthes Radial Head Prosthesis has the same indications for use, the same fundamental technological characteristics, and similar materials as the predicate Biomet ExploRTM (K051385) and Ascension (K032686) Modular Radial Head Devices,” the application read5.
The FDA agreed with the substantial equivalence and granted 510(k) approval to DePuy, allowing the company to sell the elbow implant without testing its safety.
Symptoms of Radial Head Implant Loosening
One of the biggest dangers of elbow implant loosening is that it is difficult to diagnose. A 2012 study published in the Journal of Shoulder and Elbow Surgery called the guidelines for diagnosing a loose radial head prosthesis “lacking.6”
Pain is the first symptom that there could be a problem with the elbow implant — however, the authors of the study as mentioned earlier warned that the pain could be misinterpreted.
“After post-traumatic radial head replacement, pain caused by a loose prosthesis might incorrectly be assumed to be post-traumatic,” the authors wrote.
The DePuy Synthes Radial Head Replacement recall states that elbow implant loosening can cause painful and severe side effects. Anyone who is experiencing complications from an elbow transplant should consult with an experienced attorney for personal injury compensation. Click here to learn more about elbow replacement surgery recovery, risks, and potential side effects.
Some common complications from elbow replacement surgery include9:
- Limited Mobility Of The Elbow And Poor Joint Mechanics
- Elbow Swelling And Pain
- Corrective Surgery Due To Elbow Implant Loosening
- Osteolysis (Bone Loss)
- Bone Fracture Near The Implant
- Damage Or Irritation Of Soft Tissue
A common condition found among patients who have undergone metal implant surgery is metal hypersensitivity. This condition is characterized by a disorder of the immune system and occurs when the immune system views metal as foreign threats to the body10. Some metal implant rejection symptoms include:
- Hives And Rashes
- Red, Swollen, And Itchy Skin
- Chronic Fatigue
- Chronic Joint Or Muscle Pain
A missed or misinterpreted diagnosis for radial head implant loosening can lead to more severe complications if left undetected for long periods. If you are concerned about your DePuy elbow replacement surgery or believe your osteolysis, elbow swelling, or joint pain were caused by elbow implant loosening, then contact the qualified class action attorneys at KBA Attorneys for a free case evaluation.
DePuy Elbow Implant Lawsuit
Lawsuits against DePuy over the Radial Head Prosthesis System are still in their exploratory stages. However, with thousands of people implanted with the devices and relatively low elbow replacement success rates, lawyers are expecting a wave of DePuy lawsuits.
Some of the most common claims for the DePuy elbow implant lawsuit will likely be that the company designed and manufactured a defective device, it knew or should have known the device was faulty, and it failed to warn the public about the risks.
A patient who experienced unexpected complications due to a defect in the elbow implant may be able to receive compensation for medical expenses, which can include revision surgery, follow-up visits, physical therapy, and more. Other potential financial awards could be given for pain and suffering and income lost due to revision surgery or recovery time associated with the elbow implant complication.
Although there have yet to be any verdicts or settlements related to the elbow implant, DePuy has paid out billions of dollars to victims of other defective joint implants. In 2013, Johnson & Johnson agreed to settle roughly 8,000 cases related to the DePuy
ASR metal-on-metal replacement hip for nearly $4 billion7.
Then, in 2017, a jury awarded six plaintiffs a $247 million verdict in a trial against DePuy over the Pinnacle hip replacement devices8. Thousands of additional DePuy Pinnacle cases are still pending in court.
With past cases going favorably for victims of defective products made by DePuy, those who have experienced loosening of the radial head in DePuy’s Radial Head Prosthesis System should call a lawyer to find out more about filing a lawsuit.
Qualified Elbow Replacement Surgery Attorney, Derek Braslow
This DePuy Class Action lawsuit involves many good people who have been negatively affected by elbow replacement surgery complications. Fortunately, KBA’s latest addition to its legal team, Derek Braslow brings his years of success working with and investigating defective medical devices for the firm to the benefit of KBA’s clients who have suffered bone loss (Osteolysis), bone fractures around the DePuy elbow implant, or had to have a surgery to address loosening of the DePuy Synthes elbow implant.
- Kassy McGourty. “DePuy Synthes Trauma Launches Radial Head Prosthesis System in the U.S.“, Johnson & Johnson, https://www.jnj.com/media-center/press-releases/depuy-synthes-trauma-launches-radial-head-prosthesis-system-in-the-us. Accessed September 18, 2018.
- U.S. National Library of Medicine. “Radial head fracture – aftercare“, MedlinePlus, https://medlineplus.gov/ency/patientinstructions/000561.htm. Accessed September 18, 2018.
- DePuy Synthes. “URGENT NOTICE: MEDICAL DEVICE FIELD SAFETY NOTIFICATION“, DePuy Synthes, https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/00202-17_Kundeninfo_en.pdf?__blob=publicationFile&v=1. Accessed September 18, 2018.
- FDA. “Premarket Notification 510(k)“, U.S. Food and Drug Administration, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed September 18, 2018.
- Angela F. Lassandro. “510(k) Summary – Synthes Radial Head Prosthesis System“, AccessData – FDA, https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112030.pdf. Accessed September 18, 2018.
- Shawn W. O’Driscoll, PhD, MD, FRCS, Shawn W. O’Driscoll PhD, MD, FRCS, Jonathan A. Herald, MD. “Forearm pain associated with loose radial head prostheses“, Journal of Shoulder and Elbow Surgery Board of Trustees, https://www.jshoulderelbow.org/article/S1058-2746(11)00215-1/pdf. Accessed September 18, 2018.
- BARRY MEIER. “Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants“, The New York Times, https://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html. Accessed September 18, 2018.
- Wire Services. “Dallas jury orders Johnson & Johnson to pay $247 million to hip implant patients“, Dallas News, https://www.dallasnews.com/business/health-care/2017/11/16/dallas-jury-orders-johnson-johnson-pay-247-million-hip-implant-patients. Accessed September 18, 2018.
- David Zelman. “What are common complications from elbow replacement surgery?“, WebMD, https://www.webmd.com/rheumatoid-arthritis/qa/what-are-common-complications-from-elbow-replacement-surgery. Accessed December 20, 2018.
- MedBroadcast. “Metal Hypersensitivity“, MedBroadcast, https://medbroadcast.com/condition/getcondition/metal-hypersensitivity. Accessed December 20, 2018.