Published by Complimentary Private Legal Consultation: Should you or someone close to you experience issues post-hip replacement operation, it’s imperative to get in touch with our legal team without delay. You might qualify for financial restitution by initiating a lawsuit, and our attorneys are here to assist.
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Update: FDA Warns of Increased Thigh Bone Fracture Risk with Zimmer Biomet CPT Hip System
September 17, 2024 – The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers about an increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) involving the use of a Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System) [3.].
FDA issued the warning based on information the Medicines and Healthcare products Regulatory Agency (MHRA) released on September 4, 2024, which found that “… patients with the CPT Hip System have the highest risk of fracture around the thigh bone at approximately 1.4%, and similar PTS Hip Stems have fracture rates ranging from approximately 0.6% to 1%” [4.].
Zimmer Biomet in July 2024 updated its instructions for use of the CPT Hip System due to an increased risk of thigh bone fracture. The company also announced plans to phase out the sale of the implant by the end of the year.
However, FDA has concerns about the Zimmer CPT Hip System continuing to be implanted in new patients, and the agency is working with the manufacturer to address these concerns.
Zimmer Hip Litigation Updates
To date, Zimmer has paid approximately $400 million to settle lawsuits over injuries linked to the company’s Durom Cup, and cases continue to be filed over product liability, patent litigation, and commercial litigation. Experts estimate that Zimmer will eventually be forced to pay hundreds of millions more to settle all of these cases.
Recent court verdicts relating to Zimmer hip implants include:
- $3.55 million in 2020 – An Iowa jury awarded $3.55 million to a plaintiff and her husband for injuries caused by Zimmer’s metal hip implant, which the court found was defectively designed.
- $21 million in 2020 – Courts awarded a St Louis plaintiff $20 million for severe tissue damage caused by a failed Zimmer implant, and her husband was awarded a million in a loss of consortium claim.
- $7.68 million in 2019 – In a retrial for damages, the court awarded a plaintiff $3.6 million in non-economic losses to account for future suffering.
Zimmer Hip Complications
In lawsuits filed against Zimmer Biomet, plaintiffs allege that they have suffered injuries including:
- Hip replacement loosening and separation, requiring revision surgery
- Inflammation and other adverse reactions in the tissue around the implant
- Loss of bone due to inflammation relating to debris build-up
- Metallosis (metal poisoning from metal-on-metal implants)
Pain - Trunnionosis (wear of the femoral head-neck interface)
Types of Zimmer Hip Replacements
- Zimmer Durom Acetabular Component – Implant that was used in metal-on-metal (MoM) hip replacements that could be used for both MoM resurfacing and total conventional hip replacement procedures. In July 2008, Zimmer suspended its marketing and distribution of the Durom Cup and sent a letter to U.S. orthopedic surgeons advising them to stop using the implant after an analysis of data revealed that the implant had a higher-than-expected revision rate.
- Zimmer G7 Dual Mobility Construct – Single-use implant intended for uncemented applications. The G7 is a modular system designed to offer a comprehensive portfolio of shell, fixation, and bearing options to establish a stable joint in total hip arthroplasty (THA).
- Zimmer Arcos One-Piece Femoral Revision System – Provides 3 forged titanium femoral stem options that can be adapted to a patient’s individual anatomy. The original system offered surgeons a variety of interchangeable hip replacement components, which could be implanted using a single set of instruments. The Zimmer One-Piece Femoral Revision System received FDA approval in October 2015 and was first distributed a little over a month later. It was built on the Arcos Modular Hip System introduced in 2010.
- Zimmer Echo Bi-Metric Microplasty Stem – A metaphyseal loading, fit and fill femoral prosthesis that was based on the clinically proven Bi-Metric family of hip prostheses. The Echo Bi-Metric Microplasty stem is about 30% shorter than the full-length Echo Bi-Metric stem, which is designed to conserve more of the patient’s natural bone and enable the use of minimally invasive surgical approaches.
- Zimmer Continuum Acetabular System – Combines the biological fixation of Trabecular Metal Technology with Zimmer advanced bearing options. With one comprehensive system, the Zimmer Continuum Acetabular System offers the ability to address variations of anatomy and bone quality with the bearing technology that best meets the needs of each patient.
According to a 2013 study from the National Center for Biotechnology and Information a single patient was lost to follow-up. At the last follow-up, 16 patients had died and six were contacted and had not required revision surgery; the remaining 52 patients (59 THAs) were re-evaluated and none had evidence of loosening. The Harris hip score at the last evaluation was 91.6 compared to 60.5 preoperatively [1].
As specified in a study from the National Institute of Health in 2019, no hips had evidence of acetabular osteolysis. For two hips, the radiographs showed complete acetabular radiolucent lines less than 2mm in width, with no mobilization. Trabecular distribution was homogeneous with no stress shielding. The mean annual rate of wear was 0.08mm. No instances of femoral component loosening were recorded; granulomas involving no more than five Gruën zones were seen in three cases [2].
Judge Awards $2 Million Verdict in Defective Hip Implant Lawsuit
Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective hip implant with an “unreasonably dangerous design,” following a 2-week bench trial.
According to the lawsuit, Plaintiff Michael Brian McDonald underwent hip replacement surgery in June 2010 with Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”) and a cobalt-chromium head.
Less than a year after surgery, McDonald began suffering from hip and groin pain and loss of flexibility. As a result of these problems, he was forced to undergo 2 corrective surgeries during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head, according to the lawsuit.
Judge Nan G. Nash ruled that the defective design and insufficient testing of the Zimmer hip implant caused McDonald severe, potentially irreversible harm including “metallosis“, a type of metal poisoning that occurs when the metal joints rub against each other and shed tiny ions into the tissues and bloodstream.
It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future, Judge Nash wrote. This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound.
In determining the $2.027 million in damages, Nan awarded $1 million for pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses.
FAQs
What is the typical duration of a Zimmer hip replacement lawsuit?
The duration can vary widely depending on the complexity of the case, the court’s schedule, and whether the case is settled out of court or goes to trial. It could take anywhere from several months to a few years.
Can I join an existing class-action lawsuit for Zimmer hip replacements?
Yes, if a class-action lawsuit has been filed and you meet the criteria, you may be able to join. Your attorney can help determine if joining a class-action lawsuit is appropriate for your situation.
How can I prove that my complications were caused by the Zimmer hip replacement?
Medical records, expert testimony, and documentation of symptoms and treatments can help establish a link between the implant and your complications. Your attorney will help gather and present this evidence.
Related Articles:
See all related medical device lawsuits our attorneys covered so far.
Do I Have a Zimmer Hip Lawsuit?
The Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in hip replacement lawsuits. We are handling individual litigation nationwide and are currently accepting new hip injury cases in all 50 states.
Free Case Evaluation: Again, if you have hip replacement complications, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
References:
- https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607025/
- https://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety
- https://www.gov.uk/drug-device-alerts/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-007#fn:1
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