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Synovo™ Total Hip Resurfacing System Injury Investigation
You must read the following notice before sending an e-mail message to Robins Kaplan LLP.
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
Robins Kaplan LLP is Investigating Potential Injuries Associated with Synovo Total Hip Resurfacing System
On January 3, 2024, the FDA issued a Safety Communication warning health care providers and patients, “Do Not Use Synovo Total Hip Resurfacing System.”1 The FDA advised that Synovo had “significantly modified” the Femoral Resurfacing Cup, Acetabular Fixation Cup, and Acetabular Bearing in the Synovo Total Hip System, and as a result the “safety and effectiveness” of these hip implants “have not been established.”2
The FDA recommended that individuals who had received one of these hip implants after 2019 contact their health care provider if they were experiencing new symptoms like pain, loosening, grinding or other noises in the hip, inability to bear wear, or weakness.3 It also advised health care providers to not implant Synovo Total Hip Systems, and remove from inventory their existing stock of affected products.4
After a 2022 inspection, the FDA issued a Warning Letter to Synovo in March of 2022.5 The warning letter advised the company of the various ways in which the company was not in compliance with FDA regulations.6 It noted that the company was marketing its products for non-cemented use, despite only have marketing clearance for cemented use.7 The company had also made changes to the product design without seeking the appropriate permission from the FDA.8
Contact Robins Kaplan for an Evaluation of Your Potential Case
Robins Kaplan is currently investigating potential injuries arising from these products, including premature revision surgeries to remove the components.
If you or a loved one have been harmed by the Synovo Total Hip System, including the Femoral Resurfacing Cup, Acetabular Fixation Cup, or Acetabular Bearing, and wish to discuss a potential case with our team, please call 1.800.553.9910 (toll-free) or complete our online contact form above.
About Our Mass Tort Attorneys
Robins Kaplan mass tort attorneys understand the significance of each individual's experience in cases involving defective drugs or medical devices. Our clients do not walk alone. We guide clients through the ins-and-outs of their case and help them understand the legal landscape as well as each step along the way.
1 https://www.fda.gov/medical-devices/safety-communications/do-not-use-synovo-total-hip-resurfacing-system-fda-safety-communication?utm_medium=email&utm_source=govdelivery
2 Id.
3 Id.
4 Id.
5 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synovo-production-inc-647427-03232023
6 Id.
7 Id.
8 Id.
RELATED PROFESSIONALS
Holly H. Dolejsi
Partner
Deputy Chair, Mass Tort, Personal Injury and Medical Malpractice Groups
Pronouns: she/her
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.