Who Is Zimmer Holdings, Inc.?
Based in Indiana, Zimmer Holdings, Inc is an orthopedics company that manufactures a variety of medical products. Their tools focus on skeletal and joint replacement, biologics utilized for assistance in replacement surgery, as well as other surgical tools.
Since one size does not fit all when it comes to making medical decisions, Zimmer has used the Kinectiv Modular-Neck Technology that has allowed surgeons to choose particular components of hip replacement devices that best suit the needs of individual patients. Zimmer also utilizes Trabecular Metal Technology in its products for hip surgery stabilization. This method lets the bone grow into the body’s implant through high friction of the bone tissue.
Who Are Zimmer Products For?
Zimmer products focus on Metasul metal-on-metal products and forged metal. These products are for patients needing hip replacements with tools that are designed with robustness and durable structure, unlike traditional instruments that utilize cast metal.
In 2014 Zimmer announced the acquisition of Biomet for over 13 billion dollars, which made Zimmer the second largest manufacturer of orthopedics in the U.S. In 2023 it was announced Zimmer would also acquire Embody, a company of collagen-based solutions in biointegrative injury healing.
What Is the Design of Zimmer Hip Replacement Products?
The design of Zimmer hip replacement products focuses on attachment to the femur of the leg and surrounding joints to imitate the ball and socket motions of an average hip joint. As component-based products, Zimmer’s hip replacement tools allow adaptability in shape and size to fit a patient’s proportions.
The products have four pieces, all separate, to encourage flexibility in the selection of devices. In previous years, tools were limited and patients faced a higher risk of complications if the bone did not fit with the assigned implants. Zimmer has reportedly used femoral and ace-tabular designs as well for those who have differences in bone quality.
What Is a Large Diameter Head (LDH)?
For the creation of durable and sustainable implants that will last throughout the life of a hip replacement patient, Zimmer uses metal-on-metal designs. The metal in these designs replaces the cup and ball of a non-functioning hip to allow increased flexibility during bodily movement.
The hip replacement designs created by Zimmer were constructed for younger, potentially active patients. The Durom Cup, in particular, was intended to be marketed towards young demographics due to the Metasul Tribological Solution Large Diameter Head (LDH). This head has been studied to increase stability by reducing the potential of metal dislocation within the hip. While The Durom Cup was intended to be marketed for youthful patients, according to the Global Market Insights 2023 report, elderly hip reconstruction is increasing in demand globally.
Why Was There a Recall of the Durom Cup Design?
However, the Durom Cup has had reported instances of causing adverse effects despite its durable design. Shards of metal were said to be released into surrounding tissue and the creation of the metal had slipped out of place. The Food and Drug Administration (FDA) has reported complaints and recalled the device in 2008. Later, the Durom Cup returned to market with additional training for surgeons.
What Is the history of the Zimmer Durom Cup Hip Implant Device?
Approved in 2006, within the span of a year problems began to appear with the Zimmer Durom Cup Hip Implant Device. A surgeon who had previously been a consultant to the Zimmer corporation reported failures with the metal hip device. This eventually leads to corrective surgery for patients, a costly and timely expense. It was also noted by Lawrence Dorr, MD that the Durom Cup had poor product construction. Lawrence later issued a letter to the American Association of Hip and Knee Surgeons due to his experience in the field with loose implants, inadequate surface fixation, and improper seating. These revision surgeries performed by surgeons were claimed to be due to design defects in the Durom hip implant device. Zimmer later stated that the issues were with surgical technique and not issues in device design.
Years later in July of 2008, Zimmer recalled their product under the claim of improper surgical instructions for hip replacement surgeries utilizing the Durom Cup. Until additional training was approved for release to medical professionals, Zimmer notified surgeons to discontinue implanting the Durom Cup into any new patients hereafter. The Durom Cup returned to the U.S. market again after the creation of a surgical training program that became available on the Zimmer website.
Are Metal-on-Metal Designs Approved by the FDA Today?
As complaints continued to surface after the release of the training program, by 2010 Zimmer had $69 million in compensation for injuries suffered due to the hip implant devices. It’s estimated that up to 5.7 percent of implants required or will require revision surgery due to Durom Cup design malfunction.
After being implanted in nearly 13,000 patients, in 2012 the FDA convened an advisory panel to discuss the need to monitor patients who had received metal-on-metal hip replacements due to adverse events associated with the implantation of such devices. According to the FDA, the following year in January 2013 they proposed an order for a notice regarding the recommendation to alter the requirements for all metal-on-metal hip implants from premarket notification for oversight of medical devices. By 2014, Zimmer had already paid $400 million in settlements. As of 2022, there are not currently any FDA-approved total hip replacement devices that use metal-on-metal designs like the Durom Cup.
What Are the Serious Adverse Effects and Complications of the Zimmer Hip Implant Products?
The majority of recalls related to Zimmer Hip Implant Products are due to the metal-on-metal construction in the ball and socket system. This construction has resulted in adverse effects due to the release of metal fragments into body tissue over time when patients become active again post-operation. These metal fragments can be toxic to the body, and high levels of chromium and cobalt can cause significant pain and damage.
The serious adverse events reported from Zimmer Durom Cup hip implants from metal poisoning include but are not limited to:
- Severe pain
- Instability, trouble walking
- Headaches, vertigo, or dizziness
- Optic nerve damage
- Skin rashes
- Mobility issues
- Convulsions or seizures
What Conditions May Arise Due to Zimmer Hip Implants?
The following conditions might arise as a result of Zimmer hip implants:
- Bone tissue death due to lack of blood supply
- Potentially fatal abnormal buildup of metallic debris in soft tissues
- Heterotopic ossification
- Bone tissues can grow atypically
- Periprosthetic fractures
- Fatal fractures surrounding hip implantations, occasionally leading to revision surgeries
- Masses of soft tissue surrounding the hip joints
Despite company claims of increased stability, some patients face excruciating pain from hip implant devices. As previously noted, revision surgery is often required to correct procedural mistakes.
What Is Zimmer Kinectiv Modular-Neck Technology?
Zimmer Kinectiv modular-neck technology was created for surgeons to customize hip implants or replacement devices to a patient’s personal anatomy.
What Are the Components of Zimmer Hip Products?
Zimmer hip replacement products consist of a cup, femoral components, and surgical components. Each part may have several components that make up that section of the hip implant.
What are the Acetabular Cup Components?
Acetabular cup components produce pelvic movement within the hip socket.
The Acetabular Components Produced by Zimmer Include:
- Continuum Acetabular system
- Trabecular Metal Modular Acetabular System
- Trilogy Acetabular System
- Durom Acetabular Component
What are the Femoral Components?
The femoral components include the ball, stem, neck, and head of the femoral. These components help produce elasticity and movement in the joint.
The Femoral Components Produced by Zimmer Include:
- M/L Taper Hip Prosthesis: Available in 14 sizes
- Fitmore Hip Stem
- Trabecular Metal Primary Hip Prosthesis
- VerSys Epoch FullCoat Hip
What are the Revision Surgery Components?
The revision surgery components of a Zimmer hip implant include:
- Femoral Revision Systems
- Trabecular Metal™ Acetabular Revision System
- ZMR Hip Systems
- Wagner SL Revision Hip
How Does Zimmer Kinectiv Modular-Neck Technology work?
The Zimmer Kinectiv Modular-Neck Technology authorizes surgeons to address the length, angle of insertion, size of devices, and model versions. Zimmer claims the technology can restore leg length, stability, and range of motion within the joints. The Zimmer M/L Taper Hip Prosthesis encompasses a modular neck structure designed to match different patient anatomies through stem geometry to decrease cup position alteration instances.
What Is a Modular Neck?
The modular neck in the Kinectiv technology operates for surgeons to perform a less invasive surgery than otherwise would be possible. It requires less muscle retraction to easily fit into hip placement with a variety of sizes available per patient anatomy. Ante versions and retroversions for the neck are sometimes necessary depending on the patient.
What Is a Femoral Stem?
The femoral stem in Kinectiv Technology is smaller than traditional stem technology to provide increased bone conversion.
What Are Femoral Heads?
The femoral heads are used in Kinectiv technology because they allow surgeons to fix the length, separate from the head size of the femur. Proper stabilization is then achieved of the femoral head which helps patients return to average movement of the hip joint.
What Are the Problems with Modular-neck Technology?
Like other metal-on-metal hip implants, the modular-neck technology can lead to corrosion, bone loosening, fracture fatigue, extraneous debris in the body, and induce bodily complications.
What Are Signs of Pain & Inflammation?
Pain is one of the most common complications of hip replacements using Modular-Neck Technology. Pain also commonly coincides with signs of inflammation such as redness, hip tenderness, and swelling, as well as warmth at the site of surgery.
What Leads to Metallosis & Chronic Nervous System Issues?
Complications of metallosis leave an increase in metal debris and plasma concentration due to metal friction with the device. The longer an implant has been used, the greater the risk of a metallosis instance in the body. Metallosis has previously caused multiple complications including pain, heightened inflammation, and further discoloration in and around the site of the implant. Overall, metallosis leads to chronic issues with the nervous system, specifically at the site where the hip implant was located.
How Does Modular-Neck Technology Cause Dislocation & Implant Loosening?
Modular-neck technology can cause joint dislocation as patients with hip replacement surgeries start to become more active. The implant then, over time, loosens within the body.
How Are Fractures Caused?
Metal implant fractures are common with modular-neck technology. As patients age, bone collagen content weakens and struggles to support surgical implants. Issues of fractures also tend to occur frequently in females who are postmenopausal due to hormonal bone strength changes.
What Causes Device Failure & Revision Surgery?
When the modular-neck device fails to perform in patients, due to the instrumental mechanics or dislocation of the hip, revision surgery may be a possible outcome. When a doctor is instructed to perform such a surgery, it can increase the patient’s risk more than the initial hip replacement surgery. Further damage to the hip and/or device is also possible during revision surgery.
What Are the Zimmer Hip Replacement Lawsuits?
Several lawsuits have existed against Zimmer Holdings, Inc. over the last two decades concerning the Durom Cup hip replacement technology. Zimmer has made claims in defense of legal action against their design of the modular-neck technology. They claim that the failure of the Durom Cup was in part due to surgeons not using proper hip replacement techniques in patients. The claim has not been supported by legal experts as post-surgical side-effect cases continue to be reported in high numbers, therefore Zimmer’s claims against surgical training techniques have not widely been supported.
What Zimmer Hip Replacement Lawsuit Settlements Have There Been?
Zimmer has paid almost $400 million in legal settlements regarding the Durom Cup and its failures across the population. The U.S. District Court for the District of New Jersey has had federal lawsuits held against Zimmer by multidistrict litigation (MDL) for those Durom Cup instances. Most of the cases against Zimmer for the hip replacement technology have been settled over the last 15 years, but the MDL originally had 240 cases that Judge Susan D. Wigenton oversaw.
Have the Legal Settlements Been Finalized for Zimmer?
After original legal attention was brought to Zimmer Holdings, the company stated that design improvements of the technology had taken place and that new surgical training programs were implemented to prevent future problems in the medical community from occurring. However, in April of 2008, Dr. Dorr had found new occurrences of severe side effects being reported by patients after surgery. He stated that 14 out of 165 hip replacements led to the requirement of revision surgery later on to correct the failure of the medical Durom Cup device. Over 1,700 patients have taken legal action against Zimmer as of 2022 with claims of the hope replacement device being a dangerous product with numerous failures to adequately receive accurate information and further warn patients of associated risks with the Zimmer hip replacement tools and technology.
What Zimmer Hip Replacement Lawsuit Settlements Are Expected?
Today, settlements have not been finalized for the company with the rise of additional lawsuits, and an increase in payouts expected from Zimmer is at least another $200 million. However, the Durom Cup was discontinued due to legal action in 2010, and Zimmer has settled the vast majority of complaints and cases filed against the device for its lasting effects on patients from that time period. Later, following the finalization of the Biomet acquisition, Zimmer is now the third-largest orthopedics manufacturer in the world.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.