Tuesday, February 19, 2013

DePuy issues field safety notice for ADEPT 12/14 metal modular head

Healio

DePuy, a Johnson & Johnson company issued a field safety notice dated Jan. 15 for physicians and consumers for the ADEPT 12/14 Modular Head used in total hip replacement after reviewing its revision rates in the U.K. National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.

The notice does not apply to the ADEPT hip resurfacing femoral components, according to a DePuy spokesperson. The recall, however, involves 7,700 implants sold in 21 countries, including the United Kingdom, Germany, Denmark, Australia and Canada. The heads were not sold in the United States.
Finsbury Orthopaedics Ltd. designed, developed and manufactured the ADEPT 12/14 Modular Head in 2004. DePuy acquired the firm in 2009 and then the products were acquired by MatOrtho Ltd. in 2011. DePuy issued the field safety notice due to its responsibility for monitoring ongoing performance of the product.

“Customers have been advised through the field safety notice to discontinue use and distribution of any ADEPT 12/14 Modular Heads they may still have in stock,” the DePuy spokesperson told Orthopedics Today.

The implant has a cumulative revision rate of 12.1% at 7 years, according to results DePuy officials analyzed from U.K. National Joint Registry Supplier Feedback data in November 2012. In the Australian Orthopaedic Association National Joint Replacement Registry, registry officials reported a 7.1% cumulative revision rate for the modular head at 3 years when used in total hip replacement, according to an analysis done in September 2012.

“Patients who received the ADEPT Modular Head should follow up with their doctor if they are experiencing symptoms and be treated according to local guidance/standard of care for patients receiving metal-on-metal articulations,” the DePuy representative stated. “DePuy has notified customers and appropriate regulatory agencies,” according to the spokesperson.

Reference:
www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con222579.pdf

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