DePuy Elbow Implant Recall

DePuy Synthes, a division of Johnson & Johnson, has recalled more than 50,000 Synthes Radial Head Prosthesis Systems out of concern that the radial stem may loosen post-operatively at the stem-bone interface. The U.S. Food & Drug Administration (FDA) has designated the DePuy elbow implant recall a Class II medical device recall, indicating that these components may cause temporary or medically reversible health complications.

Attorneys Representing Victims of Recalled Medical Devices

The attorneys at Bernstein Liebhard LLP have represented hundreds of individuals injured as a result of recalled medical devices, and they are now providing free, no-obligation legal reviews to the alleged victims of this DePuy elbow implant recall. To learn more about filing a claim, please contact our office by calling (888) 994-5118.

Reasons or the DePuy Elbow Implant Recall

The DePuy Synthes Radial Head Prosthesis System was granted FDA 510(K) clearance in June 2011, and is indicated for use in various elbow replacement procedures. The 510(K) clearance program does not require a device to undergo human clinical trials prior to coming to market, so long as a manufacturer can prove that the product is substantially equivalent in design to a device that had previously received FDA approval.

In December 2016, DePuy Synthes issued an “URGENT NOTICE: MEDICAL DEVICE FIELD SAFETY NOTIFICATION” to inform its customers that the Synthes Radial Head Prosthesis System was being voluntarily removed from the worldwide market. The company acted out of concern that the radial stem (the component that anchors the implant in the arm’s radius bone) could loosen at the stem-bone interface following implantation. Patients who experience this malfunction are at risk for potentially serious complications, including:

  • Osteolysis
  • Poor joint mechanics
  • Pain
  • Post-operative fracture
  • Soft tissue damage

“The entire DePuy Synthes Radial Head Prosthesis System is affected by this removal, however it is the radial stem that has the possibility of loosening post-operatively at the stem bone interface,” the company said in its notification. “Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors”

The DePuy elbow implant recall involved 50,311 units distributed throughout the U.S. In February 2017, the FDA declared the action a Class II recall. Healthcare providers who treated their patients with the DePuy Synthes Radial Head Prosthesis System have been advised to continue usual follow-up with those individuals.

Were You Affected by the DePuy Synthes Radial Head Prosthesis System Recall? Contact an Attorney Today?

Individuals who allegedly experienced complications related to the DePuy Synthes Radial Head Prosthesis System recall may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more. To discuss filing a DePuy elbow implant lawsuit, please call (888) 994-5118 to contact an attorney with our medical device practice today.

  1. FDA (June 2012) “Synthes Radial Head Prosthesis Stem – 510(K) Application” https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112030.pdf
  2. DePuy Synthes (December 2016) “URGENT NOTICE: MEDICAL DEVICE FIELD SAFETY NOTIFICATION- Product Removal 555531- Radial Head Prosthesis System” http://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/00202-17_Kundeninfo_en.pdf?__blob=publicationFile&v=1
  3. FDA (February 2017) “ Class 2 Device Recall Synthes Radial Head Prosthesis System” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
Last Modified: April 17, 2017

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