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Johnson & Johnson Unit Recalls 2 Hip Replacement Systems
Robert Lowes Posted: 08/30/2010
August 30, 2010 — An orthopaedic unit of Johnson & Johnson (J&J) is voluntarily withdrawing 2 implant systems for hip replacement after learning that roughly 1 of 8 patients in England and Wales who received the implants needed a second hip replacement operation.
The 2 devices under recall are the ASR XL Acetabular System, a metal cup fitted into the pelvis and the corresponding metal ball that replaces the femoral head, and the ASR Hip Resurfacing System, which is similar except that a metal cap is fastened to the femoral head. Both devices are manufactured by DePuy Orthopaedics of J&J. The US Food and Drug Administration (FDA) cleared the ASR XL Acetabular System for use in the United States in 2005; the ASR Hip Resurfacing System is approved in other countries, but not in the United States.
DePuy based its recall decision, announced last week, on new, unpublished data from the National Joint Registry of England and Wales showing that the 5-year rate of revision surgery after hip replacement was roughly 13% for the ASR XL Acetabular System, according to a company press release. The 5-year revision rate for the ASR Hip Resurfacing System was roughly 12%.
The company attributed these higher-than-expected revision rates to component loosening and misalignment, infection, bone fracture, dislocation, metal sensitivity, and pain.
DePuy is instructing surgeons who have implanted the hip replacement components in question to contact their patients and request a follow-up visit for evaluation. The company noted that a small number of patients may not exhibit symptoms of product failure but may nevertheless develop soft-tissue damage as a result of metal debris generated by the artificial joint. This soft tissue damage can compromise the results of a second hip replacement surgery. Accordingly, surgeons should consider metal ion testing when they are weighing revision surgery, even with asymptomatic patients.
The company stated it will cover the cost of monitoring and treating patients with hip replacements, including the cost of revision surgery.
Last year, DePuy announced that it would discontinue its ARS hip replacement product line, because of declining demand, as well as its plan to develop next-generation replacement and resurfacing technologies.
Recall Follows FDA Warning Letter on 2 Other DePuy Products
The voluntarily recall is the second setback in August for DePuy Orthopaedics. Earlier this month, the FDA ordered DePuy to stop selling its Corail Hip System because the company was marketing it for an unapproved use. In addition, the agency informed DePuy that it lacked FDA approval for a knee replacement product called TruMatch Personalized Solutions System, which uses a computed tomography scan to create a 3-dimensional model of the patient’s knee. The FDA advised the company to submit an application for product approval.
More information about the voluntary recall of the ARS hip replacement systems is available on the DePuy Orthopaedics Web site.
To report adverse events related to the ARS XL Acetabular System and the ASR Hip Resurfacing System, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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