Synovo Hip Implant Complications

Synovo Hip Implant Complications. The Synovo Total Hip System has encountered significant issues that have led to concerns from the U.S. Food and Drug Administration (FDA) and resulted in lawsuits. The Synovo Total Hip System is also referred to as the Total Hip Replacement System, and also as Synovo Preserve and Endotec BP.

Noted Side Effects of Synovo Total Hip System Replacement

Hip Bone Loss. Deterioration of bone tissue surrounding the implant over time.
Hip Implant Device Loosening. The implant may become unstable within the hip joint because of loosening.
Bearing Weight becomes challenging. Difficulty in standing or walking due to the implanted device causing pain or because of loosening.
Grinding Noises. Grinding Noises from the hip implant area during walking or standing.
Worsening Pain. Increased pain in the hip implant area.
Hip Weakness. Increased weakness and instability in the hip implant area.

FDA Warning Synovo Hip Implant

The FDA has specifically warned against the use of the Synovo Total Hip Resurfacing System due to significant modifications made to its components (the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing) after 2019 that deviate from the design initially approved by the FDA. These changes have not been established for safety or effectiveness, raising concerns about the potential for pain, device failure, and the necessity for costly revision surgeries​​​​​​.

FDA Investigation Timeline

January 2024. The FDA warned health care providers not to use Synovo Total Hip Resurfacing System due to modifications to at least three hip replacement components that make the device significantly different from the one the FDA had originally cleared for implantation.

March 2023. The FDA issued a warning letter to Synovo listing several violations and instructing the company to immediately stop manufacturing the modified devices and take prompt action to correct the violations addressed in the letter.

October 2022.The FDA concluded a two-week inspection of Synovo and determined that the company made significant changes and modifications to at least three Total Hip Replacement System components that went beyond what the FDA had originally cleared for marketing.

Sometime in 2019. Synovo made modifications to its Total Hip Replacement System without seeking FDA clearance.

What is the Synovo Total Hip Replacement System?

The Synovo Total Hip Replacement System is a medical device intended for patients undergoing total hip arthroplasty, also known as total hip replacement surgery. This system includes several components designed to replace the hip joint, aiming to restore the joint’s functionality and relieve pain typically caused by conditions like osteoarthritis.

The main components of this system are the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing. These components work together to mimic the natural movement of the hip joint.

However, it’s important to note that there have been significant modifications made to these components after their original FDA clearance. The FDA became aware of these modifications in 2022, and issued a warning in 2023 against the use of the Synovo Total Hip System due to these changes.

The FDA Inspectors noted changes to the femoral resurfacing cup, among other components, that could increase the risk of loosening and necessitate revision surgery. The agency’s concern was primarily with modifications that allowed the implant to be used in a cementless fixation, which differed from the original clearance that required bone cement.

Synovo Hip Replacement Recall

These modifications have raised concerns about the system’s safety and effectiveness, as they differ significantly from the design that was originally cleared by the FDA. The FDA has recommended against the use of this system by healthcare providers and has advised that these devices be removed from inventory​​​​.

Patients who have had a procedure using the Synovo Total Hip System, particularly since 2019, are advised to closely monitor for symptoms such as new or worsening pain, grinding or other noise, inability to bear weight, or weakness of the hip or knee on the side of the implant. The FDA does not recommend the surgical removal of these implants in patients who are not experiencing new or worsening symptoms but recommends close monitoring​​​​.

Given these findings and the FDA warnings, patients with implants from the Synovo Total Hip Replacement System should consult with their healthcare providers for personalized advice and potential follow-up care.

What is the problem with the Synovo Total Hip?

Synovo Hip Implant Complications. The Synovo Total Hip System has encountered significant issues that have led to concerns from the FDA and resulted in lawsuits. The FDA has specifically warned against the use of the Synovo Total Hip Resurfacing System due to significant modifications made to its components after 2019 that deviate from the design initially approved by the FDA.

Patients who received Synovo Total Hip System implants have been filing lawsuits due to these FDA warnings, citing modifications to the device that have led to potential risks, including pain and possible device failure, which could lead to painful and expensive revision surgeries.

Where is the Synovo Hip Implant Company based?

The Synovo hip implant company, known as Synovo Production, Inc., is based in Fullerton, California, United States.

Synovo Hip System Lawsuits

Synovo made changes to its Total Hip Replacement System components, which were not cleared by the FDA, leading to lawsuits from patients who received these implants. These modifications have raised potential risks such as pain and device failure, possibly requiring expensive revision surgeries.

Synovo Total Hip System lawsuits are the latest of hip implant manufacturers to be caught with their hand in the cookie jar. Now that they have been caught red-handed, it is no surprise that there are Synovo hip implant failure lawsuits.

Over the past decade, hip replacement device failure lawsuits have involved many thousands of plaintiffs and multi-billion dollars in jury trial verdicts and forcing these companies who released defective products into the marketplace into settlements.

Lawsuit Claims against Synovo Total Hip Implants

If you, or a loved one was implanted with a Synovo Total Hip System replacement since 2019 and required revision surgery or experienced pain or other side effects you may qualify for a Synovo lawsuit.

Please use our contact form to connect with our defective metal hip attorneys or call toll free 24 hours a day at 214-390-3189.

Our law firm’s principal office is in Dallas and we have offices in Fort Worth, Texas. Dr. Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide.

We are investigating product liability and personal injury claims for patients affected by the Synovo Total Hip Resurfacing System recall and it is time to act now. Contact Dr. Shezad Malik Law Firm today at 214-390-3189.

We work on a contingency fee basis, which means attorney fees are only earned if and only when you receive a settlement for the harm and injury caused by this defective Synovo Total Hip System medical device. Reach out to our team for a free case evaluation, and let us assist you in processing the Synovo Total Hip Resurfacing System lawsuit.

Affected Synovo Hip Brands

Synovo Total Hip Replacement System
Synovo Preserve
Endotec BP