Overview
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.
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