Its More Than Failing Hip Implants: Johnson & Johnson and DePuy Sold Medical Devices Without FDA Approval

Posted on January 20, 2012 by Laura V. Yaeger, J.D., LL.M

On December 8th, 2011, the FDA sent a warning letter to Johnson & Johnson and its subsidiary, DePuy Orthopedics highlighting that medical devices from hip implants to knee implants were sold and distributed without proper approval.

FDA Letter. The letter indicated that a number of orthopedic medical devices were misbranded or sold on the market without proper approval. Further, the FDA stressed that DePuy Johnson & Johnson's failure to obtain proper approval impacted the safety and effectiveness of the various devices, including ASR and Pinnacle Acetabular Hip Systems.

Johnson & Johnson and DePuy must now submit new 510(k) applications or PMA supplement applications on a number of its medical devices:

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

If Johnson & Johnson and DePuy fail to take corrective action the FDA may take regulatory action and issue monetary penalties.

During its inspection of DePuy, the FDA also found that DePuy’s quality systems did not comply with federal law. DePuy failed to properly analyze, track and follow up on complaints regarding its various medical devices. And many of the new quality procedures implemented by DePuy were still found to be to be inadequate.