Zimmer Hip Replacement Sales Suspended

FDA news Device Daily Bulletin Aug. 4, 2008 | Vol. 5 No. 151

Zimmer Suspends Distribution of Device, Lowers Sales Forecast
After issuing an urgent device correction letter encouraging surgeons to stop implanting its Durom Acetabular Component until they have received additional training, Zimmer Holdings lowered its sales expectations for the year.
The temporary suspension applies only to Durom Cups distributed in the U.S., where they are used in total hip replacement procedures.
Zimmer halted distribution after examining its manufacturing process and data from more than 3,100 device users in the U.S. and abroad. The investigation revealed incidents of the cups loosening and a revision surgery rate of 5.7 percent when the cup was not placed in a specific manner or “crucial technique steps” were not taken.
The company said there was no evidence of any material, design or manufacture defects. The investigation concluded that surgeons who do not use specific techniques have a lower success rate.
Zimmer will implement a training program for surgeons in the U.S., Cheryl Blanchard, the company’s chief scientific officer, says in the letter to surgeons. The company also is revising the product labeling, developing patient management guidelines, providing a guide to surgeons on talking to patients and providing direct support to patients.

The device is a cobalt-chromium alloy cup designed to be used with Zimmer’s Metasul Metal-on-Metal Tribological Solution LDH for total hip replacement. It has a titanium plasma-sprayed coating. It was launched in Europe five years ago for hip resurfacing — an alternative to hip replacement — but the FDA has not approved it for that use. It also is available in Canada, Australia, India, Korea and Argentina for hip resurfacing.


 

If you or a loved one has received a Zimmer Duron Cup Hip Replacement then you should call us toll free now at 1-866-374-0338 because you may be entitled to medical monitoring and compensation from the manufacturer.

We have represented clients in every state and helped thousands of injured clients nationwide make recoveries for their injuries. We are ready to help you! Our clients are never at risk of paying any fees, expenses, or costs out of pocket. All fees costs and expenses are paid only out of any recovery we make for you.

Get your free, no obligation claim review by a lawyer today.

  • Call us at toll free 1-866-374-0338, or
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Do not delay. Contact us now to find out if we can help. The claim evaluation is free. All claims have strict time limitations which will bar any recovery you or your loved may be entitled if the claim is not brought on time.

CALL NOW 1-866-374-0338


If you or a loved one has been implanted with a Zimmer Durom Cup Hip Implant then please call our office toll free now at 1-866-374-0338 to discuss your legal options or complete the online form. You may be entitled to medical monitoring and compensation from the manufacturer.

 



The Zimmer Durom recall has affected a large amount of people.  One of the symptoms of having a faulty hip implant is continued pain or discomfort even after the typical healing period.  From what orthopedic surgeons have been able to determine, the separation is what is causing the problem.

In order to qualify for the Zimmer Durom settlement , it is necessary to contact one of the Zimmer Durom Cup Hip Implant reps waiting to hear from you. 

Elevated numbers have been designated for the Zimmer Durom Cup Hip Revision surgeries that will be necessary to deal with the faulty zimmer Durom hip implants, as the investigation deepens, it seems these numbers are rising.

Once your initial risk free phone assessment is completed you will be in a more informed decision regarding the options available to you.

A specific division has been established at The Johnson Law Firm just to handle the Zimmer Durom recalls.  This was done to ensure that when patients call in they get the service that you deserve.  If nothing else, you owe it to yourself and your loved ones to determine if you qualify for a Zimmer Hip Lawsuit .