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DePuy™ Hip Recalls

The National Joint Registry (NJR) of England and Wales recently reported a high percentage of five year secondary or revision hip surgeries following hip replacement with The ASR™ XL Acetabular System™ manufactured by DePuy Orthopaedics, Inc., a division of Johnson & Johnson. The study showed that 1 out of every 8 patients who had received a recalled device underwent revision surgery within five years of the initial surgery.

Based on these findings, the manufacturer announced a global voluntary recall of the ASR Hip system, notifying the U.S. Food and Drug Administration (FDA) and other regulatory agencies of their plans to remove the device from the market.

Globally, approximately 93,000 people utilize one of the ASR hip implant types recalled by DePuy.

Surgeons prefer the ASR device, and other large diameter, monoblock hip resurfacing and replacement devices, for young patients who require device stability to limit repeated dislocations.

In 2009, DePuy Orthopaedics, Inc. determined it would discontinue the ASR Hip System because of declining demand, combined with an increased demand for stronger focus on emerging replacement and resurfacing technologies.

While the majority of ASR hip replacement surgeries are successful, Depuy recommends that patients utilizing the DePuy ASR device visit their implant surgeons to seek a performance evaluation. Women utilizing ASR head sizes below 50 mm in diameter are at the greatest risk.

DePuy Orthopaedics President David Floyd released the following statement:

We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.

A Bloomberg News report states federal lawsuits have been filed in San Francisco and New Jersey, and a state suit was filed in California. The San Francisco lawsuit charges that DePuy was aware for some time that patients receiving ASR hip implants required corrective surgeries because the product was defective. The Bloomberg News report also states DePuy was “fully aware” of the defect, and had received in excess of  300 reports of ASR hip failures, based on a lawsuit filed in Newark, New Jersey. The Los Angeles state court contends the DePuy ASR hip implant was rejected by the plantiff’s body because a design flaw allowed metal to grind against metal within the mechanism.

DePuy Orthopaedics, Inc. has agreed to cover reasonable and customary costs associated with monitoring, treatment and revision surgeries due to the recall.