Synovo Lawsuits: Total Hip System Implants Face FDA Warning

Have you undergone hip replacement surgery using Synovo’s Total Hip Replacement System? Then this blog is for you. On January 3, 2024, the U.S. Food and Drug Administration (FDA) issued a warning to the healthcare providers and patients who have received Synovo hip implants after 2019. What was the significance of the warning? How will it affect you? To know more on the issue, delve into the blog.

In this blog, let’s find out why people are filing Synovo lawsuits against Synovo Productions and the reason behind the FDA warning.

Why did the FDA issue warning on the Synovo Hip System?

The FDA found that Synovo had modified three components of the Total Hip System- the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing and had not received the FDA approval for the modified systems.  This Synovo Hip System is also called as Total Hip Replacement System, Synovo Preserve and Endotec BP.

Did Synovo get the FDA approval for the Total Hip System? Yes. They had received the 510(k) clearance on May 23, 1991 for this “Modified New Jersey Femoral Hip Resurfacing Component”. The Femoral Resurfacing Cup was distributed both as a stand-alone product and marketed as a component of the Total Hip System. These products are used in a range of orthopedic procedures like hip arthroplasty and reconstruction.

During the approval, the FDA had advised the manufacturers on the following:

• This device may not be labeled or promoted for non-cemented use.

• All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

• Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards and the Food and Drug Administration to conduct the investigation.

However, in 2019, they had modified the components- the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing. The FDA came to know of the modifications in 2022 and conducted an inspection in their firm located at Fullerton, CA, in October 2022.

Following that they issued a warning letter to Synovo on March 23, 2023. The inspection revealed that “the Total Hip System” which “is intended for use as a semi-constrained total hip joint replacement device composed of an acetabular fixation cup with a polyethylene bearing surface in combination with a femoral resurfacing cup…under Class III” were modified to be used for cementless fixation. “These class III device types require submission and approval of a PMA in order to obtain marketing authorization.” However, Synovo had not submitted for re-approval.

The FDA issued the warning under the following factors:

• Non-compliance with 510(k) Clearance Requirements: The Femoral Resurfacing Cup, initially cleared for cemented use only, underwent significant changes without FDA notification, including a modification for cementless fixation, which contradicts the original clearance.
• Misbranding and Adulteration: Both the Femoral Resurfacing Cup and the Total Hip System are considered misbranded and adulterated. The Femoral Resurfacing Cup is misbranded for being distributed without a new 510(k) submission for its modifications. The Total Hip System is adulterated for lacking an approved Premarket Approval (PMA) and misbranded for lack of notification for introduction into commercial distribution.
• Quality System Regulation Violations: The inspection uncovered multiple violations of the Quality System regulation, including failures in process validation, design control procedures, corrective and preventive action procedures, supplier qualification, management reviews, quality audits, and documentation of personnel training.
• Registration and Listing Requirements: Synovo has not fulfilled its annual registration and listing requirements with the FDA, rendering all its devices misbranded.

It also warned that in the labeling of Femoral Resurfacing Cup, it was mentioned as “Synovo Hip Replacement System.” However, the Total Hip System actually had other components like “Acetabular Fixation Cup” and “Acetabular Bearing.” Synovo had also changed the coating specifications given for the “Acetabular Fixation Cup,” which could potentially lead to loosening of the implant and making the patients undergo revision surgeries.

Therefore, the FDA advised Synovo to immediately cease the manufacture of the modified devices and correct the violations. Failure to address these issues might result in regulatory actions such as seizure, injunction, and civil money penalties. The FDA also noted that compliance with Federal Food, Drug, and Cosmetic Act (FD&C Act) and regulations would be considered in federal contract awards and approval of Class III devices.

Synovo is required to respond within fifteen business days, outlining specific steps taken to correct the violations and prevent their recurrence, including a timetable for such actions. The response should be comprehensive and address all violations noted in the Warning Letter and during the inspection.

The FDA also had requested Synovo to notify the customers of the risks pertaining to the modified devices.

Latest FDA Warning to Healthcare Providers & Patients

In the latest warning issued on January 3, 2024, the FDA advised the healthcare professionals to remove the Total Hip Systems and three underlying components from inventory.

Let’s see the FDA recommendations for healthcare providers:

1. The providers are asked not to purchase or implant the current Synovo hip implants.
2. They should remove the all Synovo Total Hip Systems, including the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing components used in the system from the inventory.
3. The FDA did not recommend “removal of Synovo Total Hip Systems” from individuals “who do not have any new or worsening pain or symptoms.”
4. Providers should know that the safety and efficacy of the “Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing used in the Synovo Total Hip System” were established.
5. They are asked to “discuss with patients considering hip implants the benefits and risks of all relevant treatment options, including alternative legally marketed hip implant devices.”
6. They should monitor individuals who have received the Synovo Total Hip System, -“resurfacing implants, for potential bone loss or device loosening, wear or failure.” They are also requested to obtain “X-rays to further evaluate a patient and their implanted device” if they suspect failure of the implant.
7. They are requested to review the FDA recommendations for the patients who had got any parts of the Synovo Total Hip Replacement System.

The FDA advises the patients to contact the healthcare provider if experiencing new symptoms like “worsening pain, loosening, grinding or other noise, inability to bear weight, or weakness of the hip or knee on the side of your implant.” In case of no pain or worsening symptoms, the FDA does not recommend surgical removal of the system.

What could be the side effects of Synovo device failure?

Apart from the side effects or symptoms noted above by the FDA, the patients may encounter issues like the ones listed below:

• Dislocation of the implant
• Implant materials causing allergies
• Bone fractures
• Wear and tear of the implant
• Infection on the side of the implant

Synovo Lawsuits Update 2024

Synovo lawsuits are still in infancy with only a few lawsuits filed. After the FDA warning in January 2024, attorneys across the nation started investigating the possibilities of the claim and evidence to establish the damages.

How to file a Synovo Lawsuit?

Synovo hip replacement system victims can be entitled to various forms of reparation. To determine eligibility for a Synovo hip replacement lawsuit, individuals must meet specific criteria. Scheduling a consultation with a Synovo lawsuit attorney who has secured favorable jury verdicts for plaintiffs in defective medical device claims is a crucial step.

Another significant step is substantiating the harm. Medical records of the victim can act as solid evidence in proving the harm ensued from the defective Synovo implant. Ensure that your medical records are intact and included all the crucial details of the date of the device implant, make and model of the device and the side effects or the symptoms pertaining to the defective device after the implant and so on.

Getting an experienced medical record review company to review your medical records can bolster your claim. They can easily cherry pick the vital evidence from your voluminous records. When the strengths and weaknesses of your claim are identified, it would be easy for your attorney to battle against the defendants.

Eligibility criteria for pursuing a Synovo total hip lawsuit include the following:

• Victim has received the hip implant and experienced pain or other symptoms
• Device failure necessitated revision surgery or other hospitalizations
• Received any one of the components of the Total Hip System
• The components were manufactured after the modifications done in 2019

However, seeking a legal counsel on time will help you know the eligibility of your Synovo lawsuit.

Other Hip Replacement Lawsuits on the Go

As of February 2024, there are many cases pending in the hip replacement lawsuits MDLs against various manufacturers.

Exactech Lawsuits: Exactech hip replacement lawsuits are still alive with around 1,169 pending cases in MDL 3044.

DePuy Lawsuits: There are 240 pending Depuy hip replacement lawsuits in MDL 2197. The lawsuits alleged failure of Hip Replacement Resurfacing System implants.

Smith & Nephew Lawsuits: Around 170 open cases are there in the Smith & Nephew lawsuits MDL 2775. These lawsuits purported device loosening and failures in Birmingham Hip Resurfacing System and R3 Acetabular System.

Stryker Lawsuits: There are 264 lawsuits in the MDL 2768 (Stryker LFIT V40 Femoral Head Products Liability Litigation) and 72 cases in the MDL 2441 (Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation). Plaintiffs in the Stryker lawsuits accused loosening of Tritanium Acetabular Shells.

Wright Profemur Hip lawsuits: In MDL 2949, there are only 27 cases against MicroPort and Wright Medical as they had settled most of the claims out of the court for more than $300 million since 2015.

Zimmer Lawsuits: In MDL 2859 (Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis with Kinectiv Technology and Versys Femoral Head Products Liability Litigation), there are 305 pending cases. Zimmer hip replacement lawsuit settlement was made for a $314 million in other lawsuits. The plaintiffs alleged that the Durom cup implant failed to fuse.

To wrap up,

The FDA’s warning underscores the importance of prioritizing patient safety and the need for stringent adherence to regulatory processes within the medical device industry. Patients, healthcare providers, and legal professionals must remain vigilant and informed about the evolving situation surrounding Synovo Total Hip Systems to ensure the best possible outcomes in Synovo lawsuits for those affected.

As the spotlight focuses on Synovo’s Total Hip Replacement System following the FDA warning, individuals affected by these modified components must be informed and proactive. Engaging a knowledgeable attorney and understanding the intricacies of the FDA’s concerns can be pivotal steps in pursuing justice and compensation for those impacted by Synovo’s hip replacement systems.

Keep in touch with us know the latest Synovo lawsuits update 2024.