DePuy Ordered To Recall Thousands Of Custom Orthopedic Implants

The Food and Drug Administration (FDA) ordered DePuy Orthopaedics to recall over 8,300 unused custom orthopedic implants since DePuy failed to comply with FDA guidelines. This recent recall is another source of negative publicity for the medical device manufacturer. DePuy is currently dealing with a number of lawsuits filed by patients who were harmed by their defective ASR hip implants. Now the Johnson & Johnson subsidiary is recalling another set of medical devices two years after the ASR hip implants were removed from the market.

Sometimes the orthopedic implants manufactured by DePuy needed to be custom-made for certain patients. The physicians would contact the company and request an implant be made to fit a patient’s specific shape and size. DePuy proceeded to create a custom-made implant so that the patient could use it.

In December 2011, the FDA submitted a letter to DePuy stating that the customized implants were being sold without FDA approval. DePuy was required to submit an application to the FDA and perform clinical trials before selling the custom implants. DePuy assumed the custom implants were exempt from standard FDA approval rules because the orthopedic devices were already granted approval by the FDA. DePuy was merely modifying the devices so that they could properly fit patients.

FDA stated that DePuy was violating the law because altering a device’s specifications to fit a patient’s anatomy does not mean the device is exempt from standard approval procedures. A marketing application still needed to be submitted. The devices also needed to be tested for their effectiveness and safety before being sold on the market. FDA further claimed that DePuy implemented poor quality control procedures while creating the different custom orthopedic implants.

Since DePuy failed to properly interpret and execute the distribution of their devices according to FDA rules, the company had to recall all of its unused custom orthopedic devices. In January 2012, DePuy stopped producing custom implants after FDA submitted the warning letter about the rules violations. DePuy also has to take back the devices already delivered to physicians that hadn’t been used on patients yet. The exact number of implants included in the recalled is unknown but more than 8,300 of the devices were distributed since 1999.

DePuy is still in the midst of litigation involving their ASR hip replacement devices. The hip replacement devices were poorly designed. The device had a high failure rate. Metal shavings would chip off of the devices. Some patients suffered from metal poisoning. The hip replacement devices would also move out of place causing the patient to be in pain as he or she tried to move around. The company had to recall about 93,000 hip replacement devices. Many patients underwent revision surgery to get the hip device removed so that they could alleviate their pain. More than 8,000 people have filed lawsuits against DePuy in order to be compensated for the damage caused by the defective hip devices.

If you or a loved one has been injured by a defective medical device, speak with a personal injury lawyer. Schedule a free consultation with a personal injury lawyer so that your case can be evaluated. The personal injury lawyer will assess your legal options and determine if you are entitled to receive compensation.

This article was contributed by Andy Sampson, Client Manager for Price Benowitz LLP


Author: Editor

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