DePuy Recalls Another Metal Hip

While a jury listens to evidence about Johnson & Johnson’s DePuy Orthopaedics’s failed ASR metal-on-metal hip replacement device in a Los Angeles courtroom, the company issued a field safety notice on January 15, 2013 for physicians and consumers for the Adept 12/14 Modular Head used in total hip replacement. This was done after reviewing revision rates of the device from the UK National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.

The notice stated that a review of post-market surveillance data suggests a higher-than-expected revision rate for the head when used in conventional total hip arthroplasty. Analysis of UK National Joint Registry Supplier Feedback data (download 11th November 2012) indicates a cumulative revision rate of 12.1% at seven years for the head when used in conventional total hip arthroplasty.

When this combination is used with the Adept cementless stem, the data showed a cumulative revision rate of 9.7% at five years. This is based on 17 revisions in a cohort of 195 implantations.

The head was manufactured by Finsbury Orthopaedics Ltd., which was acquired by DePuy in December 2009. The devices were available commercially from Finsbury or DePuy from 2004 to September 2011. From September 2011, the heads were acquired by MatOrtho Ltd. DePuy issued the field safety notice due to its responsibility for monitoring ongoing performance of the product.

Sales of the device were reportedly halted in 2011, but apparently 7, 500 of the implants spread to 21 different countries including the UK, Germany, Denmark, Australia and Canada. None were sold in the U.S.

The notice involves the top part of the devices and the company notes that a similarly named product called the Adept Hip Resurfacing Femoral Components was not recalled.

Customer Directions

Customers are being told that if they have any remaining inventory to please cease further distribution or use of the product with immediate effect.

The company is asking customers to undertake the following urgent actions:

• Quarantine/Bond any Adept 12/14 Modular Head inventory that is located at your facility or hospital
• Arrange with your local DePuy representative to return for credit any unused implants
• Please sign and return a confirmation/reconciliation letter to the specified DePuy contact
• Please ensure all departments and colleagues within your organization who are impacted by this Field Safety Corrective Action notification are made aware of this action

Patient Care

Patients who have received the Adept head should be followed according to local guidance/standard of care for patients receiving metal-on-metal articulations.