Hip Implant Failure
DePuy - Wright - Biomet - Zimmer - Johnson & Johnson
Depuy ASR Hip Implant and Wright Conserve Hip Implant Litigation
All Metal on Metal Hip Replacements are Subject to Early Failure
A March 13, 2012 medical journal article published by The Lancet lends further support to a rapidly growing collection of published literature finding that metal-on-metal total hip replacements fail at unacceptably high rates. By reviewing the world's largest database on hip replacements, the National Joint Registry of England and Wales, the study's authors were able to analyze over 400,000 procedures up to 7 years post-surgery. According to the study, metal-on-metal hip implants have a 5-year revision rate of nearly 6.2% (compared to less than 2% for other articulations) and an 8-year revision rate of over 10% (compared to about 2% for other articulations). The study concludes that metal-on-metal implants "have poor implant survival compared with other options and should not be implanted." Notably, the study finds that "all types of metal-on-metal prostheses are prone to early failure."
KBL represents consumers who have suffered as a result of the failure of DePuy ASR Hip Implants and Wright Conserve Hip Implants.
Several studies have determined that the DePuy ASR™ implants have been failing for various reasons such as cup loosening, metallosis and high levels of cobalt-chromium ions in a patient's body. The ASR devices were formally recalled on August 24, 2010. The DePuy recall letter noted revision rates of 13% after 5 years, which were already higher than industry standards. New data presented at the British Hip Society Annual Conference in March 2011 revealed a failure rate of 21% at 4 years and 49% at 6 years! This means a patient with an ASR device has an almost 50% chance of needing a revision surgery to replace it after only 6 years.
The DePuy ASR™ Acetabular Cup System® Implants Fail Due to Design Defects The metal acetabular cup rests on and moves directly against the metal femoral head. The design defects appear to be related to the ASR device's component materials and the friction which transfers directly to the acetabulum. DePuy ASR ™Acetabular Cups are forged out of cobalt chrome. Physicians and their patients have discovered that, after even short periods of time, the rubbing of metal-on-metal in the artificial joint releases metal debris which allows the cobalt and chrome ions to escape and disperse to nearby parts of the body. When the debris and ions relocate, they can infiltrate organs, produce local irritation, or even create cysts.
The DePuy ASR™ device's design inherently causes friction between the femoral head and the acetabular cup, creating even more initial friction during leg movement than other similar implants. The elevated friction is transferred to the acetabulum from the junction between the acetabulum and the acetabular cup.
The Wright Medical Conserve® Cup features a similar design to the DePuy ASR™ Cup. The Wright Conserve® Hip Implant System is a metal-on-metal design, which consists of cast cobalt chromium molybdenum that provides the receptacle for the cobalt chromium molybdenum femoral head. The metal femoral head rotates within the metal monoblock Conserve® Cup, without a liner, resulting in the release of metal particles that can cause metal toxicity in the blood, soft tissue and bone. This can result in metallosis, tissue necrosis, pseudotumors and other serious health problems.
Since the FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) premarket approval system, hundreds of adverse event reports have been submitted to the FDA by patients and physicians. In May 2011, the FDA asked Wright Medical and other metal-on-metal hip makers such as DePuy, Stryker and Zimmer, to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and to quantify the potential side effects of metallosis.
FDA Safety Communication: Metal-on-Metal Hip Implants
Date Issued: Jan. 17, 2013
- Orthopaedic surgeons
- Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
- Patients who are considering or have received a metal-on-metal hip implant
Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors
Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.
There are two types of metal-on-metal hip implants1:
- Traditional total hip replacement systems
- Resurfacing hip systems
Purpose: In February 2011, the FDA launched a metal-on-metal hip implant
webpage2. The FDA is providing updated safety information and recommendations to patients and health care providers. This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.
Summary of Problem and Scope:
Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants3.
In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”
Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).
Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.
Wright Medical Technologies Pending Litigation
On Monday, March 19, 2012, in an effort to promote the convenience of all parties in California involved in litigation concerning metal-on-metal hip implants manufactured by Wright Medical Technologies, Inc., Kiesel Boucher & Larson, LLP, on behalf of its client Mary Wright, took the initiative to petition the California Judicial Council to coordinate all related proceedings. There already exists numerous cases against Wright Medical Technologies pending in different Counties throughout California. The Petition "further anticipates hundreds, if not thousands of additional cases to be filed in California courts" in the coming months.
Coordination of the Wright metal-on-metal hip implant cases is intended to benefit all parties and promote judicial efficiency. The goal is to alleviate the burden on the Courts by avoiding the need for multiple judges to needlessly review and adjudicate the same or similar issues multiple times, especially when each case involves similar injuries arising from the same product manufactured by the same defendants.
The Petition notes that in each of these cases, the plaintiffs allege that Wright Medical Technologies "knew or should have known that the Wright Hip System was defective and likely to fail, and . . . as a result of the defendants' actions and their use of the defective hip implant systems, the metal-on-metal hip devices failed and/or caused metal ion debris to be released in the plaintiffs' bodies, causing injury." Furthermore, each of the plaintiffs "allege similar injuries, including breakage, metalosis and necrosis to the tissue, often requiring a suffering plaintiff to undergo a painful revision surgery."
In requesting that the cases be coordinated in Los Angeles County, the Petition reasons that Los Angeles, as "the nerve-center for many doctors who were trained, or trained others, in the implantation of these metal-on-metal devices," is the home of several potential plaintiffs, key witnesses and documents. Therefore, it would serve the convenience of the parties to have the cases coordinated in Los Angeles County.
Chief Justice of the California Supreme Court, the Honorable Tani Cantil-Sakauye, acting as Chair of the California Judicial Council, will review the Petition and assign a coordination motion judge to determine whether coordination is appropriate and set a hearing date. Kiesel Boucher & Larson anticipates that the petition will be before a coordination motion judge within six weeks.