Synovo Total Hip System Lawsuit

Lawsuits against Synovo Productions, Inc. are on the rise following the FDA's warnings regarding significant unauthorized modifications to their Total Hip System device since 2019. These legal actions target issues such as persistent pain, device malfunctions, and the need for invasive revision surgeries. Individuals who underwent surgery for a Synovo Total Hip System replacement and encountered complications or necessitated revision surgery may qualify for compensation.

First Name*

Last Name*

Email Address*

Phone*

Message

This verification is required.
Privacy Policy and Terms of Service apply.

Meyers & Flowers: Pursuing Justice for Synovo Total Hip System Injuries

The Synovo Total Hip System has been associated with serious complications, causing physical discomfort, emotional distress, and financial burdens.

At Meyers & Flowers, we believe in holding those responsible for these injuries accountable. We fight for fair compensation to cover medical expenses, lost wages, pain and suffering, and other damages.

If you or a loved one has experienced complications related to the Synovo Total Hip System, contact us today for a free consultation. Let us help you seek the justice and compensation you deserve.

Background of Synovo Total Hip System Lawsuit

Synovo introduced the Total Hip System to help patients needing hip arthroplasty, a procedure to replace a damaged hip joint with a prosthesis. This medical device aims to restore mobility and alleviate pain for those with degenerative joint diseases like osteoarthritis. However, individuals who underwent a Synovo Total Hip System implant have initiated legal action following the FDA’s warnings regarding significant modifications to the device, which deviated from the FDA-approved design. While lawsuits are in their preliminary phases, there have been no notable settlements or jury decisions announced.

Here’s what you need to know:

Lawsuits began when patients experienced post-surgery complications, which they attributed to the implant's design and material composition.
The litigation surrounding the Synovo Total Hip System focuses on the safety and efficacy of the device, with claimants alleging that the system has caused them harm or has failed prematurely.
These claims often highlight problems such as device failure, metallosis, and other complications that could lead to additional surgeries or medical interventions.
Allegations against the manufacturer include failing to adequately test the hip system before its market release and providing misleading information about its safety and efficacy.

Synovo Hip Replacement Potential Side Effects

The modified Synovo hip replacement products can lead to a spectrum of side effects, varying from mild to severe, and in certain instances, surgery may be necessary for device removal.

Side effects from a Synovo implant device may include:

Inflammation: You might experience swelling around the surgery site.
Wear of Component: Parts of the implant may wear down over time.
Implant Loosening: The device may become loose, leading to pain or malfunction.
Metal Sensitivity: Some patients could have allergic reactions to metal components.
Osteolysis: Loss of bone around the implant can occur, potentially leading to implant failure.

The FDA’s Issued Safety Warnings

On January 3, 2024, the FDA issued a vital safety communication directing healthcare providers to refrain from using or purchasing the Synovo Total Hip System, including:

Acetabular Fixation Cup

This component is key to securing the hip socket in place. Concerns raised led to a recall to ensure patient safety.

Femoral Resurfacing Cup

An essential part of the hip joint that interfaces with the thigh bone. Similar to the fixation cup, this component was also recalled.

Acetabular Bearing

The bearing is crucial for the smooth movement of the hip joint and was another component subject to recall.

The FDA has determined that these components underwent significant modifications without proper clearance, casting doubts on their safety and efficacy.The FDA indicated the changes made to the devices may increase the risk of the components loosening. This can lead to breaks in the component, complete device failure, bone loss, and fractures, which will require revision surgery.

Key FDA recommendations include the following:

Immediately stop using the Synovo Total Hip Systems
Remove all units from your current inventory
For patients with implants, watch for signs of potential device failure, including bone loss or loosening
Obtain diagnostic X-rays if device failure is suspected and maintain recommended follow-up schedules
Inform patients of all treatment options, emphasizing the benefits and risks associated with each, and share the FDA’s patient recommendations with those who have the system implanted
Device removal is not suggested if patients show no new or worsening symptoms.

The agency discovered the unauthorized modifications in October 2022 during an inspection of the Synovo facilities. The FDA responded by warning Synovo to halt production of the altered devices and rectify the listed violations. Additionally, they requested that Synovo inform their customers about the risks of these modifications.

Investigation Timeline

2019

Synovo modified its Total Hip Replacement System without obtaining clearance from the FDA

October 2022

Following a two-week inspection, the FDA determined that Synovo had made substantial changes to at least three components of the Total Hip Replacement System, exceeding the scope of the original clearance for marketing.

March 2023

The FDA issued a warning letter to Synovo, identifying multiple violations. The letter demanded an immediate halt to the production of modified devices and prompt remedial actions to address the violations outlined.

January 2024

The FDA issued a safety warning to healthcare providers against utilizing the Synovo Total Hip Resurfacing System, citing the modifications to hip replacement components rendered the device notably different from the FDA-approved version initially cleared for implantation.

March 2024

Synovo Production issued a "Urgent Medical Device Recall" notification to all affected consignees for three components of the device including: Acetabular Bearing, Acetabular Fixation Cup, and Femoral Resurfacing Cup

Who Could Be Eligible For A Lawsuit?

You may be eligible to file a lawsuit if you or your loved one received a Synovo hip replacement and required revision surgery or experienced pain or other side effects. These lawsuits hinge on allegations of product defect, failure to warn, and negligence in the manufacturing process.

Eligibility to join typically hinges on the following factors:

Medical Complications: You may be eligible if you've suffered from severe side effects after the specific model or version of the Synovo Total Hip System was implanted in your body, such as metallosis (metal poisoning), device failure, or necessary revision surgery.
Timing of the Procedure: Your eligibility could depend on when you received your hip implant. Cutoff dates may depend on when the product was recalled or known to be faulty.
Evidence of Manufacturer Negligence: Prove that Synovo failed to warn about potential risks or breached its duty of care through negligence or misconduct.
Statute of Limitations: Legal action must be taken within a specific timeframe after injury or diagnosis, which varies by state.
Documentation: You must possess appropriate medical records, surgical reports, and any documentation depicting the pain and suffering caused by the implant.

Below is a checklist of what you may need to qualify:

Proof of Synovo Total Hip System implantation
Medical records detailing complications
Date of original hip replacement surgery
Information on any revision surgeries
Expert medical opinions linking complications to the implant
Timeline fitting within your state’s statute of limitations

Choose Meyers & Flowers for Synovo Total Hip System Lawsuit Representation

At Meyers & Flowers, our experienced team specializes in medical device litigation to provide you with a strong and proficient approach to your case. We have a proven track record of successful outcomes in complex lawsuits and a deep understanding of medical product law.

Choosing Meyers & Flowers for legal representation means you will benefit from thorough preparation and strategic execution in court. Our attorneys stay updated on the latest developments in medical litigation, giving them the knowledge needed to challenge strong opposition.

You don't have to navigate the path to justice alone, and we are here to provide the support you need. For more information about the Synovo Total Hip System lawsuit, contact Meyers & Flowers to schedule a consultation and explore your options for remedy and restitution.