FDA panel backs approval for J&J hip replacement

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WASHINGTON (AP) — A panel of federal health experts on Tuesday unanimously recommended approval for an experimental hip replacement system from health care products maker Johnson & Johnson.

The Food and Drug Administration’s outside panel of orthopedic experts voted 5-0 that the Pinnacle Complete implant system appears safe and effective, according to an agency spokeswoman.

Panelists recommended approval, provided the New Brunswick, N.J.-based company conduct a 10-year follow-up safety study.

The FDA is not required to follow the panel’s advice, though it usually does.

J&J’s Depuy unit has asked the FDA to approve its device for patients who need a total replacement of the ball-and-socket hip joint due to damage or deterioration. A diseased hip joint can cause pain and disability.

About 193,000 total hip replacements are performed in the U.S. each year, according to the American Academy of Orthopedic surgeons.

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