The U.S. Food and Drug Administration (FDA) issued a warning to Johnson & Johnson subsidiary, DePuy Orthopaedics, for manufacturing and marketing several unapproved orthopedic medical devices.
According to the warning letter, DePuy manufactured and sold over a dozen different orthopedic devices without having received regulatory approval from the FDA. DePuy was also accused of having a quality assurance system in place that was not in compliance with FDA mandates.
The warning letter was sent by the FDA’s Director of Compliance on December 8, 2011, following an inspection of DePuy’s Warsaw, Indiana location that was conducted on May 10, 2011 through June 7, 2011. The warning states that DePuy manufactured and marketed fourteen (14) orthopedic devices, including knee and hip systems that never received FDA approval. These devices the FDA specified include:
- 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
DePuy stated that it believed the devices were distributed without approval or clearance under the belief that they are custom made devices for individual patients and were exempt from the FDA’s premarket approval or clearance process. The FDA responded by stating that the devices did not meet the agency’s criteria. Silverman stated in the warning letter, “The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices,”
DePuy was also cited by the FDA for failing to comply with quality regulations, including not having sufficient procedures in place to ensure the orthopedic devices met patient’s needs, failing to have proper complaint review procedures, and not ensuring DePuy employees handling nonconformance issues were notified when a product was not in conformance.
If you or a loved one have been injured by a defective hip implant, call a Sarasota product liability attorney today from the personal injury law firm of Lutz, Bobo & Telfair, P.A. Our lawyers may be able to help. Our law firm offers no cost consultations for personal injury cases. Our fees are also handled on a contingency basis. This means that we only charge attorney’s fees if we win the case.