Faulty Medical Device Damages
The defective implant attorneys at Keefe Bartels consistently obtain exceptional results. We have recovered millions of dollars for clients suffering from faulty medical implant devices, while earning a nationwide reputation as a leader in defective medical implant litigation. Our attorneys provide aggressive legal representation to ensure successful settlements and verdicts for our clients.
Revision Hip Replacement
Hip replacement surgeries are one of the most common procedures performed by orthopedic surgeons. This procedure carries with it a very high success rate. However, if something does go wrong with the implant, a revision surgery on the hip may be required. In many cases, revision hip surgeries are a result of the prosthesis wearing out. The lifespan for an artificial hip can range from 10 years to over 30 years however; the end result is always the same; all hip implants will eventually wear out and require replacing. Common reasons for the implant wearing out can include a fractured or loosened implant, premature wear of the plastic components, infection, or a break in the supporting bone around the implant or other trauma.
Normal wear of a hip implant is expected, however it is important to recognize the difference between normal wear and a defective implant joint. Numerous hip implant products have come to light in litigation as being defective including products from major hip implant manufacturers such as Stryker, Zimmer, Centerpulse Orthopedics (formerly Sulzer Orthopedics), Smith & Nephew, and Howmedica. A revision surgery may be recommended for these defective hip implant products to remedy the failed medical device situation.
Hip Replacement Product Recalls
Depuy Implant Recalls:(Depuy is a subsidiary of Johnson and Johnson)
This implant manufacturer was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. The recall was mandated by the Food and Drug Administration after numerous reports that the femoral head component was fracturing at a larger rate than what was expected. Depuy Orthopedics was one of the eight manufacturers that issued recalls of their hip implant systems as a result of using St. Gobain Desmarquest’s zirconia ceramic femoral heads in their joint replacement products.
In the late 1990s, Depuy withdrew its Hylamer Polyethylene Bearing Surface product from the market. This product was originally developed to minimize wear in join implant components for the hip, shoulders, knees, and elbows. In 2001, the British government’s Medical Devices Agency issued a recall of knee implant Hylamer liners sterilized with gamma radiation in air. The recall was conducted after a study showed that patients were showing a high failure rate for the device.
In 2008, Depuy issued another recall on its LCS Knee – Orthopedic knee implant Meniscal bearing insert. This product is intended to replace a knee joint in order to relieve pain and restore function to the knee. The reason for the recall was that the product was not labeled properly and mis-etched as to size.
In August 2010, Depuy recalled its ASR Total Hip Implant as well as its ASR Resurfacing Device due to high failure rates. Keefe Bartels is currently litigating these types of cases throughout the country, and was recently appointed co-lead counsel for all ASR cases filed in the state of New Jersey.
Smith & Nephew Implant Recalls
This London based medical device manufacturer issued a recall of its Genesis II and Profix II Knee Implants to the Food and Drug Administration in 2003. The recall was a result of the failure of the knee implant systems to bond properly to the bone when implanted. This caused increased pain and loosened joints in patients with the knee implant systems. The failure of these knee implant products led a number of patients to have additional surgeries to fix the problem. These additional surgeries resulted in longer rehabilitation times for the patient and also heightened risks during the operation.
In 2007, Smith & Nephew issued another recall after a subcontractor incorrectly packaged the medical manufacturer’s BIRMINGHAM Hip Resurfacing System implants. As a result of the subcontractor error, different sizes of acetabular cups were packaged together.
Smith & Nephew began another voluntary recall in January of 2008 of its TC-PLUS, VKS, and RT-PLUS product lines. The medical implant manufacturer was informed by one of its suppliers that the semi-finished knee implant castings contained higher-than-specified iron content. The products being recalled were manufactured by Smith & Nephew’s subsidiary, Plus Orthopedics.
Biomet Implant Recalls
Biomet was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. As mentioned previously, this recall was initiated after authorities had found that the component was breaking at a rate that was higher than expected.
In 2007, Biomet issued a recall of its Tibial Bearing ARCOM UHMWPE, sterile. The reason for this recall was improper laser etching for size.
In 2008, Biomet issued another recall. This recall was on its Biomet brand Modular Microplasty Cup Insertor which is an instrument for its hip prosthesis acetabular cup component. The reason for the recall was that the weld at the lock location could break during impaction.
In October 2012, the Federal Judicial Panel on Multidistrict Litigation ordered that all Biomet M2a Magnum hip implant cases be coordinated in the US District Court for the Northern District of Indiana. The Biomet M2a Magnum hip implant is a metal-on-metal hip implant. Patients with this implant have suffered injuries as a result of metal particles being shed from the device and resulting in serious personal injuries.
Encore Orthopedics Recalls
Encore was also a part of the 2001 recall of St. Gobain Desmarquest manufactured zirconia ceramic femoral heads.
In 2004, Encore Orthopedics initiated a recall due to labels being switched on two of its products, Foundation Knee System, and 3DKnee System. The 3D Knee System products were labeled as Foundation Knee Systems and the Foundation Knee Systems were labeled as 3D Knee Systems.
In 2008, Encore Orthopedics recalled its Foundation Knee System Tibial Fixed Impactor component. The reason for the recall is that the company began to receive reports from surgeons that the Nitronic 60 screw on the Tibial Fixed Impactor was fracturing during surgery. Encore initiated another recall in 2008 on its 3DKNEE Tibial Insert Trial, a device used in surgery to determine the right size of 3DKnee component to implant. The Tibial Insert Trial was being incorrectly marked for thickness.
Howmedica Implant Recalls (A Subsidiary of Stryker, Corp.)
Howmedica was one of the manufacturers that had to recall its products due to St. Gobain Desmarquest manufacturing problem with its femoral heads.
In early 2008, Stryker issued a recall on its Trident Hip Implants. The FDA issued a warning in 2007 to Stryker Corporation after patients were complaining that the implant was causing “squeaky hips” and joint pains. Patients were also reporting that the implants were even breaking and causing the individual difficulty when performing simple tasks such as walking. The complications that some patients were experiencing caused them to have additional surgeries in an attempt to remedy the situation. The recalled implants were being manufactured at the company’s Ireland facility and sold in the United States. The FDA claims that Stryker failed to fix manufacturing problems which led to problems in patients. According to the FDA, the following list of Stryker products could be defective due to the manufacturing issues:
- Trident PSL Acetabular Shells
- ReUnion Plasma Spray Humeral Stem
- Solar Plasma Purefix HA Shoulder Stems
- Duracon Total Knee Modular Femoral Component
- Global Modular Hip Stems
- Trident PSL HA Solid Black 52 MM
- Trident Hemispherical Cluster 50 MM
- Hip Implant components with ceramic bearing components
- Sulzer Medica Recalls (Now Centerpulse Orthopedics)
- Sulzer Orthopedics, a subsidiary of Sulzer Medica, issued a recall in 2001 after the company found a manufacturing error with its knee implant systems. The implants were being contaminated with an oil residue during the manufacturing process. The lubricant residue inhibited the ability for the implant to bond efficiently to neighboring bone. Sulzer reached a $750 million settlement with patients in the United States for this manufacturing error due to the fact that thousands of individuals had to undergo additional surgeries.
Wright Medical Recalls:
In 2004, Wright Medical issued a recall on its metal acetabular hip cups that are used in the company’s CONSERVE(R) Total and CONSERVE(R) Plus hip systems. The reason for the recall was a manufacturer defect that resulted in a seam or ridge in the inner acetabular cup surface. This defect caused the component to fail.
On February 8, 2012, the United States Judicial Panel on Multi-District Litigation (“JPML”) transferred four cases involving the Wright Medical Conserve Hip Implant System to the United States District Court for the Northern District of Georgia.
Patients allege that Wright Medical manufactured the Conserve Plus metal-on-metal hip implant in a defective manner and failed to warn them about the potential risk that the device may fail causing serious medical problems and the need of revision surgery. Plaintiffs further allege that the Conserve acetabular cup has a tendency to loosen and fail as metal particles are shed into the body as the ball and cup articulate against each other.
Zimmer was another medical manufacturer that was a part of the St. Gobain Desmarquest manufacturing problem with its zirconia ceramic femoral heads.
In 2008, Zimmer issued a recall on its Durom Cup Replacement product after thousands of the product had already been used in thousands of patients since its approval in 2006. Physicians began to see a problem in their patients when some started complaining about continuous pain after the normal healing timeframe. A number of these patients were forced to have revision surgeries to repair the problem. A few months after the recall, Zimmer’s Durom Cup Replacement was back on the market. However, this time they posted additional product training on their website for physicians. Zimmer claimed that this new training would teach surgeons on how to use their product properly which would cut down on problems. Zimmer admits that it did a poor job at training doctors on using its product when it was first released. Zimmer’s shareholders were also unhappy with the fact that the company took a long time to even notify its stakeholders of the current issues with the Durom Cup product. The company’s shareholders filed a class action lawsuit in response to Zimmer’s way of handling the situation.
Centerpulse Orthopedics (Sulzer) Hip Implant Recall
There have been numerous issues with hip implant systems over the years. For example, in early 2001, Sulzer Orthopedics (now Centerpulse Orthopedics) issued a recall of its hip replacement products due to the growing number of adverse reports from doctors using the implant on patients. After a two month investigation, it was found that a small amount of lubricant residue was being left on the implant during the manufacturing process. This hip replacement product was meant to snap into place and for bone to actually grow into it. The lubricant residue left on the implant interfered with the bonding which caused the implant to fail and required some patients to have revision surgery to remedy the situation.
Femoral Head Recall
In late 2001, 8 hip implant manufacturing companies (Apex Surgical; Biomet, Inc.; DePuy Orthopaedics, Inc.; Encore Orthopedics, Inc.; Osteoimplant Technology Inc.; Smith & Nephew, Inc.; Stryker Howmedica Osteonics; and Zimmer, Inc.) issued recalls due to a problem with the zirconia ceramic femoral head component, which was manufactured by St. Gobain Desmarquest. This component (which connects the femoral stem to the pelvis) was fracturing at a higher rate than what was expected, as early as 13 to 27 months after the initial implantation. If the hip implant fractured in patients, serious injury including pain and suffering from the implant was caused and a revision surgery was necessary.
Stryker “Squeaky Hip” Warning Letter
In late 2007, Stryker’s manufacturing facility in Mahwah, New Jersey was issued a warning letter from the FDA for manufacturing problems in conjunction with malfunctioning hip implant components. Some of these malfunctions led to device failure and required revision surgeries to repair the problem. In the letter, the FDA cited a number of complaints where patients describe an array of issues with the implants including squeaking noises, problems walking, and extreme pain and suffering. During an inspection in 2007, the FDA uncovered a litany of problems at Stryker’s New Jersey facility including bacterial contamination. The FDA stated in the warning letter that the problems found at Stryker’s manufacturing plant directly contributed to the failure of the defective hip products.
On July 4th, Stryker Corp. voluntarily recalled its Rejuvenate Modular and ABG II hip implants. (The Rejuvenate Modular and ABG II Hip implants were approved by the FDA in 2008 and have since been implanted in over tens of thousands of patients throughout the United States. Documented complaints include:
- Metal PoisoningMetallosisAdverse Local Tissue ReactionsALVAL (aseptic lymphocyte dominated vasculitis associated lesion)
- Squeaky Joints
- Pain and Discomfort around the area of surgery
- Parts breaking and wearing off in the body
- Bone Fractures
- Muscle Damage
It is important to note that just because a hip or knee implant device has not been recalled does not mean that it is not defective. Manufacturers strenuously resist calls to remove a device from the market, despite strong evidence from patients and doctors indicating that a device is unsafe. Keefe Bartels has successfully litigated hundreds of medical device implant claims involving devices that were never recalled. If you or a loved one has a knee or hip implant device that has failed and been removed, please contact us today for a free consultation.