Over the last decade, numerous hip replacement devices have been recalled following reports of failure and injuries. Shortly after the recalls and in the years following, thousands of defective hip implant lawsuits were filed against the product manufacturers, many of which are still pending today. The result of cases like the Stryker hip replacement lawsuits has been billions of dollars in settlements and jury awards paid to patients with failed implants.
Patients have suffered harm and required complex and painful revision surgery due to defective hip implants that have corroded, fretted, and broken inside their bodies. Now, the FDA has warned about another possible problem with a total hip system, this time manufactured by Synovo Products Inc. The company may soon be facing hip replacement lawsuits like so many others in the industry.
Given the dangers of the Synovo Total Hip System, anyone with a failed implant should speak with an experienced defective products attorney who can protect their rights and recover compensation.
On January 3, 2024, the U.S. Food and Drug Administration (FDA) issued a Safety Communication with clear instructions: Do Not Use Synovo Total Hip Resurfacing System. They provided recommendations for patients who received Synovo Total Hip Systems after 2019 – systems that contained the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and/or the Acetabular Bearing.
The FDA also made recommendations to health care providers considering using the Synovo Total Hip System, including resurfacing implants. They stated that the three components had been “significantly modified” from what had been approved and that the safety and effectiveness of these parts had not been established.
Some of the dangers of the Synovo Total Hip Replacement System include potential bone loss or device loosening and wear or failure. The FDA recommended health care providers closely monitor patients with the affected implant. They also advised providers not to implant or purchase the Synovo Total Hip System and to remove the implants from inventory.
When the communication was issued, the FDA didn’t recommend the surgical removal of affected hip implants from patients who aren’t experiencing new or worsening symptoms of device failure, such as pain or instability.
The FDA Safety Communication also had recommendations for patients who received the Synovo Total Hip Systems after 2019. Essentially, patients should be vigilant about any changes to their health.
Anyone with an affected Synovo implant should contact their health care provider if they experience any of the following symptoms of a failed hip replacement:
At this time, patients with the device do not need to have it removed. Unfortunately, if you experience any of the symptoms noted above, it may be a sign your Synovo hip implant has failed, and you may require revision surgery. It’s important to see your doctor as soon as possible if changes occur.
You should also report the issue through the MedWatch Voluntary Reporting Form. MedWatch helps protect consumers and patients from faulty or defective medical devices, harmful medications, biologics, and other FDA-regulated products. Reporting adverse events can protect others, prevent future harm, and help hold companies liable if they were negligent.
For Synovo, the Safety Communication by the FDA regarding the dangers of Synovo Total Hip Systems should not have been a surprise, as this was not the first time the agency raised concerns about their product. An inspection in October 2022 led the FDA to issue a warning letter to Synovo in March 2023.
The letter noted several violations regarding significant changes to the Femoral Resurfacing Cup’s fixation – and that the changes, including to coating specifications and differences in intended use, were made without approval. Such changes were noted to put patients at increased risk of loosening and the need for revision surgery.
The FDA letter explained that Synovo did not submit the necessary modification paperwork. They further noted that they consider the modified Femoral Resurfacing Cup to be misbranded due to the manufacturer’s failure to seek clearance.
The warning letter to Synovo identified seven FDA violations, but there could have been more. Synovo was instructed to immediately stop manufacturing the Total Hip System and modified Femoral Resurfacing Cup, and to correct the violations. They were further warned that regulatory action would be taken by the FDA “without further notice” if they didn’t address the violations.
Consumers and patients place trust in the hands of manufacturers of joint replacement systems, with the hope that this surgery will improve their mobility and quality of life. But when a company fails to follow the correct FDA procedures that are in place to protect the public, and people suffer because of such negligence, there must be accountability.
Sadly, our defective products lawyers have seen many patients suffer unnecessarily due to the negligence of hip replacement manufacturers. Current and past clients have had to undergo revision surgery for failed hip implants far sooner than they should have, leading to painful and lengthy recoveries.
Based on our firm’s experience and industry trends, the lack of proof around the safety and effectiveness of significantly changed Synovo Total Hip System components indicates there may be risks of device failure and other complications.
Hip replacement revision surgery is costly, requires time off work to recover, and many patients pay out-of-pocket expenses. A hip replacement lawsuit can help compensate patients for financial damages, pain and suffering, and other effects of a defective medical device.
The FDA’s recent Safety Communication is clear. The safety and effectiveness of the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and/or the Acetabular Bearing in Synovo Total Hip Systems implanted after 2019 is unknown, and patients may be at risk. As a result, Synovo may face hip implant lawsuits soon if the affected devices fail.
At Childers, Schlueter & Smith, our product liability attorneys have represented defective joint replacement victims for years; we know the ins and outs of hip implants, how and why they fail, and the widespread effects of fractured, corroded, or fretted components. If your hip replacement failed and you were injured and/or require(d) revision surgery, our defective products attorneys can help. Contact us online or at 1-800-641-0098 for a free consultation.
