Thursday, November 3, 2011

Complaints of Adverse Events Skyrocket For Pinnacle Hip Implant

 

I reprinted this in response to the blog post yesterday as it is an updated chart of the FDA complaints.  I like to present the other side of this story.  You would think I would be panicked by this given my surgeon chose the Pinnacle for my revision on monday.  REMEMBER, it is my belief and my surgeon's belief that these complaints are likely related to the metal on metal Pinnacle hip.

It would be great if Depuy would come out and confirm or deny this.  In my surgery, we will be using one which has the following configuration:

  • titanium head
  • poly liner
  • ceramic ball.
Nevertheless, I think it is important to know this data.  Likely there are many patients out there with the metal on metal Pinnacle.  Also, these comments below are not ones which I agree with but it is fair game  to acknowledge that there may be other opinions!

by Brian Devine on October 9, 2011
Our office just finished reviewing updated complaint data reported by the FDA about the DePuy Pinnacle hip implant. The results continue to alarm us. Based on complaint data reported through September 24, 2011, it is clear that that complaints about the Pinnacle hip implant are increasing rapidly.

Over 700 adverse event reports were filed with the FDA in just the last three months (July-September 2011.) This compares to 556 adverse event reports that were filed in the previous six months (January – June 2011) and 556 reports that were filed in all of 2010.

It is perplexing to us why the Food and Drug Administration has not yet recalled the Pinnacle hip implant. Over 2,500 adverse event reports have been filed with the FDA regarding the Pinnacle hip implant. To put this into perspective, in August 2010 when the FDA announced the DePuy ASR hip replacement recall, half the number of adverse event reports had been filed for the ASR (1,195) as have now been reported for the Pinnacle (2,500.)

The following chart shows the history of adverse event reports for the Pinnacle hip implant:
Many of these reports are similar to the complaints that were reported for the DePuy ASR hip implant, which led to a massive hip replacement recall. For example, many doctors have reported that Pinnacle hip implants are failing due to a large amount of metal degrading from the implant. The problems with all metal-on-metal implant has recently been addressed by the media, including NBC Nightly News and The New York Times.

Despite the rapidly rising number of complaints, the FDA still has not forced DePuy to recall the Pinnacle hip implant. DePuy continues to sell the Pinnacle hip implant to unsuspecting patients who likely are not being told about the number of adverse events reports that have been filed with the FDA.
Brian Devine, a former insider at an orthopedic company who now represents victims of DePuy’s hip implants, is concerned that the FDA may be allowing a defective hip implant to remain on the market. Brian Devine filed the first lawsuit involving the Pinnacle hip implant six months ago in October 2010. Since then, more than 500 lawsuits have been filed across the country.

6 comments:

  1. Wow! This can be a single of the most effective blogs I’ve actually arrive throughout on this subject. Basically Magnificent.

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  2. Thanks! send in comments or observations or questions.

    Connie

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  3. My husband had a pinnacle metal on metal implanted on 2/14/2008 and was in extreme pain almost immediately. I asked if there was any chance he had a reaction to the implant and was told it was not possible. My husband has been on c2 narc's for years now and all of his complaints were ignored.On 11/11/2011 he had a hip revision and had a pocket of ALVAL which was probably good that it was contained because it is basically metal poisoning. He had so many classic symptoms of metal poisoning and not one of his complaints was taken seriously.Since the revision he is in less pain than he has been in years even post op. If you haven't heard of alval please look it up it is really important to know the signs so it can be addressed.

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  4. It's not really suitable to be implanted in human body.

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  5. Much better not to undergo hip replacement surgery.

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  6. My guess is that the FDA cannot issue a recall of the Pinnacle hip implant based simply on the issued complaints. It has to order or do rigorous testing of the mentioned products before a valid recall can be issued. Meanwhile it is unfortunate that patients suffer from complications and the implant, if it proves to be faulty, will cause lots of problems for the patients.

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