What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

May 17, 2011

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?

If you think you have a DePuy hip implant and would like to know more about the case, give our offices a call at 1-800-677-7095. Our people are standing by to answer your questions and explain how we can help.

DePuy Crib Sheets

Deciding what you want to do in the aftermath of this hip recall is extremely difficult. There are important medical and legal decisions to make, and you may not be feeling up to the task of figuring out the right questions to ask. We thought we'd try to make that a little easier for you.

Medical Crib Sheets

Legal Crib Sheets

Learn more about the DePuy Hip Recall Cheat Sheets or just go right ahead and download them - they're absolutely free and we hope they help during this difficult time.

DePuy Recall In The News

As new updates appear in the news on the DePuy hip recall and the ASR XL Acetabular System, we put those links up here so you can stay informed. If you'd like to be notified when we have news updates, please subscribe to our feed.

August 22, 2012
Johnson & Johnson Agrees to Pay About $200,000 Per Case to Settle Three ASR Lawsuits in Nevada
www.washpost.bloomberg.com

June 27, 2012
FDA Holds Hearing on Metal Hips But Dodges Fundamental Question of Inadequacy of Testing
www.nytimes.com

March 12, 2012
Too Little Too Late? Researchers Conclude Metal on Metal Hip Replacements Should Not Be Used.
www.bbc.co.uk

»Read our complete archive of articles about the Depuy hip recall.

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Have Questions?

We've got answers. We've compiled a list of the most frequently asked questions we receive from incoming clients and given you our most informed answers. We explain the lawsuit, why you don't need to spend any money to hire an attorney, and the risks to your health.

You can also browse our Stay Informed section for full articles on the case against DePuy and the medical problems with the ASR XL Acetabular total hip replacement system, or contact us directly.

View our FAQs on the DePuy hip recall.

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