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FDA Sends Warning Letter to DePuy for Unapproved Implants

FDA Sends Warning Letter to DePuy for Unapproved Implants

January 19, 2012 — The U.S. Food and Drug Administration (FDA) has sent a warning letter to DePuy Orthopaedics Inc., a subsidiary company of Johnson & Johnson that manufacturers synthetic hip, knee, and ankle implants.

The FDA is citing the company for failing to receive the necessary FDA approval of its products before selling them on the U.S. market. The FDA warning letter has prompted the company to stop selling some of its products.

In January 2012, the FDA inspection found numerous problems. The biggest problem was that some of their medical products were illegally marketed, because the company sold them without receiving FDA approval.

The FDA found that DePuy does not have approved applications for pre-market approval of medical devices, or applications that would exempt investigational devices from approval. The company also failed to notify the FDA of its intent to sell the medical devices commercially.

The FDA found that the following products have no pre-market clearance or approval:

  • PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads
  • PFC Sigma Knee System components, sizes 2.5, 7, and 8
  • PFC Sigma Knee System, 30 mm – 40 mm thick inserts
  • Agility Total Ankle Prosthesis talar components with stems 0.35 inches and longer
  • Agility Total Ankle Prosthesis talar stems that are round in cross-section and taper downwards
  • The Agility Total Ankle Prosthesis augments
  • Global humeral stems 18 mm in diameter
  • Global Humeral Stems shorter than 120 mm in length
  • TriFlange Acetabular Cups with outer diameters greater than 66 mm
  • TriFlange Acetabular Cups indicated for cemented use
  • Femoral heads that include a 14/16 taper
  • Femoral heads with offsets greater than +12
  • Acetabular hip system 14/16 taper adapters
  • Adapters to Stryker hip components

The warning letter acknowledges that DePuy distributed the devices without FDA-approval because it believed that since they were “custom” devices, they were exempt from the FDA approval process. The FDA found that just because the devices came in a variety of sizes and shapes, they were essentially a standardized design that could be shared among doctors, and thus did not qualify for a “custom” exemption from the FDA approval or clinical studies to determine the safety and effectiveness of the products.

The FDA also cited the company for failing to meet quality standards for a company selling medical devices. The company had no procedures to accomplish the following tasks: review consumer complaints, notify the employee in charge of nonconformance when a product was found nonconformant, or ensure devices conformed to user needs.

How do I contact a Lawyer for a Defective DePuy Implant Lawsuit?

The Schmidt Firm, PLLC is currently accepting defective DePuy implant injury cases in all 50 states. If you or somebody you know has suffered from a defective DePuy implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our DePuy Implant Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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