Hip Implants Recalled Because of Potential Fracture Problem

A problem with an artificial hip component has prompted a widespread recall by the manufacturer, here in the US and abroad. The component of the implant is the femoral head. That's the ball portion of the hip prosthesis that connects the femoral stem to the pelvis.

This particular femoral head is made of a zirconia ceramic, and it's manufactured by a French company, St. Gobain Demarquest. The French company supplied the component to a number of other manufacturers who make the finished implants.

This component was recalled because it was fracturing at a higher rate than expected within about 2 years after the hips were implanted. Eight United States companies that manufacture the finished implants are voluntarily recalling them as well, because they contain this component.

If you use hip implants in your facility and you want to identify the specific products and batches that were recalled, you can get this information on our web site. The web address will be listed at the close of the broadcast.

The recall doesn't mean that all of these components are expected to fail, or that all patients will experience a problem. Unfortunately, there's no way to predict which implants are going to fail.

FDA is not recommending surgery to replace any hip implants that have not fractured or aren't causing problems. But clinicians may choose to monitor the performance of these implants more closely, and watch for patients complaining of a sudden onset of pain in the implanted hip joint. Some patients have reported hearing a "pop" from their hip just before experiencing this pain.

Additional Information:

FDA Talk Paper: Hip Implants Being Recalled; Potential Fracture Problem. September 14, 2001.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01102.html

FDA Notice: Recall of Zirconia Ceramic Femoral Heads for Hip Implants. September 13, 2001.
http://www.fda.gov/cdrh/recalls/zirconiahip.html

Category:

News & Politics

Tags:

• Hip
• Implant
• Recall
• Fracture
• FDA
• Prosthesis
• Patient
• Safety

[andreucolo]

@sergiu25 ciao sergiu, io avevo il tuo stesso problema ( coxartrosis) mi sono operato a 25 anni, ho una protesi totale ... non honessun problema, però sono stato recalled anche io. ciao dall' Italia.

[julesisagimp]

this guy is a total faggot, obviously takes it up the shitter........

[sergiu25]

i have problem ..i have coxartrosis and i have 20 years i can do 1 operation?i i need total hip replacemant ?

i can?