DePuy Orthopaedics, a business unit of J&J that makes joint replacements, announced a voluntary recall last week of two hip-replacement products, the ASR XL acetabular system and DePuy ASR hip resurfacing system.
The recall was initiated because the company recently received data showing that a greater number of people than expected had experienced pain and trouble walking with the systems and needed a second surgical procedure, called a revision surgery, in which a second hip replacement was performed. Specifically, five years after the initial hip replacement, approximately 12% of patients who had received the ASR resurfacing device and 13% of patients who had received the ASR total hip replacement needed to have a revision surgery, according to the recall notice.
DePuy advises patients who believe they have one of the recalled joint replacements to consult with their surgeon for testing and evaluation of the function of the joint-replacement system. For those experiencing pain or difficulty walking, x-rays and other imaging techniques, blood tests, and possibly additional surgery may be required, according to the recall notice. DePuy’s announcement tells patients the company will cover the “reasonable and customary costs of testing and treatment if you need services, including revision surgery, associated with the recall of ASR.” The company also provides a release form that patients can submit to DePuy allowing the company to contact healthcare providers in cases where patients do not know what kind of hip replacement they have.
The two recalled hip-replacement systems were not involved in the FDA Warning Letter that DePuy received last week for marketing violations. The letter was issued because FDA said it never approved the sale of DePuy’s TruMatch Personalized Solution System, a device that features proprietary software and a CT scanner that produces a three-dimensional model of a patient’s knee prior to knee-replacement surgery. FDA’s letter also states that DePuy marketed its Corail Hip System for two uses that were not approved by the agency. FDA asked DePuy to stop marketing the products and correct the violations detailed in the letter.