DePuy recalls ASR Hip System due to revision rates

DePuy Orthopaedics Inc., Warsaw, U.S.A., has voluntarily recalled two of its ASR hip replacement components — the ASR XL Acetabular System and the ASR Hip Resurfacing System — due to the rates of revision surgery with them.

New, unpublished data from the National Joint Registry of England and Wales (NJR) show a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System. Those revision rates included all ranges of component sizes, but the revision risk was highest with ASR head sizes less than 50 mm in diameter and among women, according to an August 26 press release from DePuy Orthopaedics.

“We regret that this recall will be concerning for patients, their family members and surgeons,” David Floyd, president of DePuy Orthopaedics Inc., stated in the release. “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.”

The next step

According to the release, as of August 27, patients and health care professionals can call special phone numbers with recall-related questions or go to depuy.com. DePuy stated in the release that it is providing hospital, surgeons and patients with comprehensive information about the recall to help them decide the next best steps in each case. Noted in the release, while the majority of ASR hip replacement surgeries have been successful, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

The ASR Hip Resurfacing System, introduced in 2003, is only approved for use outside the United States; however the ASR XL Acetabular System, launched in 2004, was available worldwide.

DePuy stated in the release that few of these devices remain on the worldwide market due to its decision last year to discontinue the ASR system as a result of declining demand and other factors.

Previous data

Previous post-market surveillance data from a variety of sources — including national joint replacement registries, published literature, company-sponsored clinical trials, internal complaints data and unpublished clinical research reports — showed lower revision rates and that the ASR hip implant was performing in line with other large-diameter monoblock hip resurfacing and replacement components, according to the release.

DePuy has notified the FDA and other regulatory agencies globally of the recall.

Recently DePuy Orthopaedics received a warning letter from the FDA about its marketing of two other systems. The company said it is reviewing that letter to understand the agency’s concerns and respond to them.

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DePuy Orthopaedics Inc., Warsaw, U.S.A., has voluntarily recalled two of its ASR hip replacement components — the ASR XL Acetabular System and the ASR Hip Resurfacing System — due to the rates of revision surgery with them.

New, unpublished data from the National Joint Registry of England and Wales (NJR) show a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System. Those revision rates included all ranges of component sizes, but the revision risk was highest with ASR head sizes less than 50 mm in diameter and among women, according to an August 26 press release from DePuy Orthopaedics.

“We regret that this recall will be concerning for patients, their family members and surgeons,” David Floyd, president of DePuy Orthopaedics Inc., stated in the release. “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.”

The next step

According to the release, as of August 27, patients and health care professionals can call special phone numbers with recall-related questions or go to depuy.com. DePuy stated in the release that it is providing hospital, surgeons and patients with comprehensive information about the recall to help them decide the next best steps in each case. Noted in the release, while the majority of ASR hip replacement surgeries have been successful, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

The ASR Hip Resurfacing System, introduced in 2003, is only approved for use outside the United States; however the ASR XL Acetabular System, launched in 2004, was available worldwide.

DePuy stated in the release that few of these devices remain on the worldwide market due to its decision last year to discontinue the ASR system as a result of declining demand and other factors.

Previous data

Previous post-market surveillance data from a variety of sources — including national joint replacement registries, published literature, company-sponsored clinical trials, internal complaints data and unpublished clinical research reports — showed lower revision rates and that the ASR hip implant was performing in line with other large-diameter monoblock hip resurfacing and replacement components, according to the release.

DePuy has notified the FDA and other regulatory agencies globally of the recall.

Recently DePuy Orthopaedics received a warning letter from the FDA about its marketing of two other systems. The company said it is reviewing that letter to understand the agency’s concerns and respond to them.

Reference:

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