Defective Metal Hip Recall and Replacement. From the early 2000’s there was a trend to using metal-on-metal hip replacements for degenerative hip disease, and unfortunately, these metal implants can cause permanent physical damage to patients.
Metal debris causes local and generalized injury
Many medical studies have shown that the metal debris that leaches out from the device (usually cobalt and chromium) can destroy muscle, bone, and soft tissue around the artificial implant. This is known as metallosis.
The microscopic metal debris occurs because of the grinding motion between the metal ball and metal cup during normal activity. The released metal shavings have nowhere to go except locally into the hip joint or generally be absorbed into the body via the bloodstream.
The metal debris absorbed through the body causes organ damage (heart, liver, and kidney), deafness, loss of sight, and other serious medical illnesses such as dementia.
The only treatment for a defective and degenerating metal hip implant is revision surgery to remove the affected parts and replace them with a new hip implant with either a ceramic ball or plastic insert between the ball and cup.
Quiet Recall or Removal from market
The medical device companies that made and sold metal on metal hips either recalled them or quietly removed them from the market and no longer sold the metal-on-metal hip replacements.
What is a Hip Implant?
An artificial hip replacement is a common type of surgery where a damaged hip joint is replaced with an artificial one (known as an implant).
Adults of any age can be considered for a hip replacement, although most are done on people between the ages of 60 and 80.
A modern artificial hip joint is designed to last for at least 15 years. Most people have a significant reduction in pain and improvement in their range of movement.
Thousands of lawsuits filed, settled, and are still ongoing
Thousands of patients have filed lawsuits against the companies that produced these hips and plaintiffs have won multi-million dollar trial verdicts against them.
Lawsuits are ongoing against Johnson & Johnson for their DePuy Pinnacle hip, Zimmer Biomet Orthopaedics for their M2a Magnum hips, Exactech for their Exactech Connexion GXL hip, Stryker for their Stryker Rejuvenate and Stryker ABG II hips, Wright for their Wright Medical Conserve and Wright Medical Profemur hips, Smith and Nephew for their Smith and Nephew Birmingham and R3 hips.
Exactech Hip Implant Lawsuit
Recently an Exactech Hip Implant lawsuit was filed in Arkansas, alleging that an implant used during hip implant surgery was defectively designed, manufactured, marketed, and sold. According to the lawsuit, the Exactech implant has a polyethylene liner which has a high rate of early failure from wear and tear, causing severe bone degeneration known as secondary osteolysis.
Exactech Connexion GXL liner recall
Exactech, Inc., is the orthopedic device manufacturer of the Exactech Connexion GXL hip implant. Nearly 90,000 Exactech Connexion GXL liners have been implanted in patients undergoing hip replacement.
In June 2021, Exactech, Inc., issued a Class II Medical Device Recall of its Connexion GXL acetabular polyethylene liners used in hip implants.
Exactech’s reason for the recall was that the “risk of edge-loading and premature prosthesis wear” was possible. Medical studies have shown a general link between catastrophic early polyethylene wear and the use of the Exactech Connexion GXL liner.
These studies found that the plastic Exactech Connexion GXL liners in hip implants failed in five years or less.
Problems with the Recalled Exactech Connexion GXL Liner
The Exactech Connexion GXL acetabular liner is made of ultra-high-molecular-weight polyethylene plastic. According to Exactech, its acetabular liners are made using a special radiation and compression process that results in less surface damage and wear and tear. But, these claims are not supported by current patient experiences who are having problems with the early wear and tear of their plastic inserts.
Texas AG Announced $120 Million Settlement with Johnson & Johnson for Falsely Marketing Hip Replacement Devices
In January 2019, Texas Attorney General announced that Texas will receive $8.5 million as part of a $120 million multistate settlement with Johnson & Johnson and its DePuy Orthopaedics subsidiary unit. This settlement is based on alleged unfair and deceptive marketing of the two metal-on-metal hip replacement devices.
Texas and 45 other states alleged that Johnson and Johnson and DePuy made false claims about the longevity of the ASR XL and Pinnacle Ultamet metal-on-metal hip implant devices. Patients who underwent hip replacements with the devices later complained of a variety of health issues, including premature hip implant failure and metal poisoning known as metallosis. The ASR XL was recalled from the market in 2010 and the Pinnacle Ultamet was discontinued in 2013.
According to the Texas Attorney General, “Companies that falsely market their medical products dangerously jeopardize patients’ health in order to increase profits, and consumers must be able to trust that the advertised benefits of hip implant devices are backed by solid scientific evidence, not exaggerated claims.”
Under terms of the settlement, DePuy agreed to revise how it markets and promotes its hip implants, including the use of current scientific data to support claims it makes in advertising the products.
The Texas Attorney General and his counterpart from South Carolina led the investigation into Johnson and Johnson and DuPuy with an executive committee consisting of the attorneys general of Florida, Indiana, North Carolina, Ohio, Pennsylvania, and Washington. Also participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.
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