January 19, 2012 — The FDA is warning DePuy Orthopaedics Inc. that it is violating the law by selling its “custom” synthetic hip, knee, and ankle replacements without FDA approval.
The FDA warning letter has resulted in DePuy halting sales of several of its products, until clinical safety studies can be conducted and official FDA approval is granted.
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FDA Warning Letter to DePuy
The FDA warning letter, sent in January 2012, was the result of an inspection of DePuy Orthopaedics Inc. The inspection found many problems, which were outlined in the warning letter. The FDA found that DePuy was illegally marketing its “custom” orthopedic devices, because they were being sold without FDA approval. In addition, the agency found that DePuy lacked applications for pre-market FDA approval of medical devices. They also failed to provide applications for exempting their devices from approval. In short, the company failed to notify the FDA that it planned to market and sell the implants in the United States, as is required for medical devices.
The following list of products was found to be in violation of the law for failing to obtain pre-market clearance, undergo clinical trials, or gain FDA 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
DePuy countered the FDA assertions by claiming that it believed the devices were exempt from FDA approval or clinical trials because they were “custom” devices. The FDA found that the devices did not qualify as “custom” medical devices. Although they were tailored for different people and manufactured in a variety of shapes and sizes, the product design was standardized, and could be shared among doctors. The FDA thus determined that the DePuy implants would need to go through clinical trials and the same approval process as other medical devices before they could legally be sold in the United States market.
The federal agency also warned that DePuy failed to meet federal regulations for quality standards in the administration of a medical device company. The firm lacked procedures to review complaints made by customers, notify their own employee in charge of nonconformance when a product was found to be nonconformant, or ensure that that medical devices actually met a customer’s needs when it was implanted.
The FDA warning letter comes on the heels of intense scrutiny of DePuy, after the company recalled the ASR XL Acetabular Hip Replacement System for being defective. The hip replacements were found to fail in 13% of hip-replacement patients, according to a study conducted in the United Kingdom. This failure rate is significantly higher than other hip implants.