During this same period, Zimmer, Inc. has put up a new website devoted to explaining and defending the Durom acetabular cup.  The website, http://zimmerduromhip.com, has a home page describing the cup, a page dedicated to their investigation of the cup, a page for frequently asked questions, and a general information page on hip replacements.

While it is still unclear exactly why the Durom has demonstrated such high revision rates in the first few years after implantation, many experts have speculated that the subhemispherical design and circumferential fins were preventing the cup from making full contact with the bone in the pelvis.

The newly designed product description can be found on Zimmer’s website, here.

To read more from Barry Meier, look at his full article.

These studies covered products by different manufacturers, such as DePuy Orthopaedics, Smith & Nephew, and Zimmer, Inc., as well as products used for both resurfacing procedures and total hip replacements.  While The DePuy product presented evidence of metalic debris which caused damage to muscles, tendons and soft tissues in some cases, the Zimmer Durom resulted in a significantly higher rate of metal ions in patients.  The article says this about studies on the Durom:

“The British Columbia researchers reported that patients receiving a conventional implant with a Durom socket, or “cup” as it is known, had significantly higher median blood serum levels of chromium and cobalt — 2.6 times for chromium and 10 times higher for cobalt — than patients who underwent resurfacing with the Durom system.

Those researchers, whose study was underwritten by Zimmer, urged in their report that the Durom components no longer be used in standard implants because of “these excessively high metal ion levels.” In this country, the Durom product is used only in conventional implants; the resurfacing system is not approved for sale.”

Issues with metal-on-metal hips are becoming more apparent, even as companies such as Zimmer, Inc. deny that there is anything wrong with their products’ design.  With the help of interested surgeons and reporters such as Barry Meier, we will continue to put pressure on medical device manufacturers to produce safe, well tested devices, and be open and honest about the products they put on the market.

Shareholders argue that Zimmer was well aware of problems with the Zimmer Durom, long before they gave their guidance for 2008.   Among the evidence presented in the recently filed amended complaint is information that Zimmer’s officials knew about the Zimmer Durom.

One of the confidential witnesses is a former Director of Communications for Zimmer who was appointed to the crisis team that investigated the Durom failures.  According to the complaint, this witness verified that top Zimmer officials knew about Dorr’s warnings for many months, and it wasn’t until the issue became public that they put together a team to investigate the problem.  The complaint says this about Zimmer’s crisis team:

Instead of ascertaining the truth of the Durom Cup’s reported defects, the crisis team was tasked with searching for evidence to support the Company’s position that surgeons were to blame.  CW16 expolained that it took many months before Zimmer took action and as a result hundreds of people likely received a Durom Cup implanted in the interim period.

To learn more about evidence put forth in this complaint regarding Zimmer’s reckless and profit driven  actions, please read the complaint in the following link:

Amended Complaint

Zimmer Correction and Removal Report

Despite the case being dismissed, the complaint presents interesting information.  Jim Crines, Zimmer Holdings’ CFO, is quoted in the complaint, from a presentation at the Deutsche Bank Securities Inc. Health Care Conference on May 6, 2008, saying:

“I will also tell you that we did receive…indications in the European market in the early part of 2007 with a couple of surgeons in France.  We were able to trace their experiences to issues with the technique that they were using.  This is a cup that once it’s seated up into the acetabulum cannot be repositioned.  And we have had situations where – this particular situation in France a couple of surgeons had experienced early failures as a result of the technique that they were using where they were repositioning the cup after it had been seated up into the acetabulum.  Se we were able to address that particular issue with surgical technique training.

 That’s an issue I can tell you that we paid a lot of attention to here in the U.S. as this product has been launched into the U.S. There’s a lot of information that’s provided to our sales reps, training that’s provided to our sales reps, so they’re able to convey to any surgeons that are using this device the importance of following the technique.”

This statement is interesting in light of Zimmer’s current stance in regard to the Durom failures.  That being, the Durom cup in Europe has had remarkable success, and surgeons over there were not reporting any difficulty.  It appears by Mr. Crines’ statement that they were indeed reporting failures very similar to those occuring in the US, and they were not addressed in the US until the sales suspension, nearly 2 years later.

To read more, take a look at the pdf of the Complaint filed in Plumbers and Pipefitters Local v. Zimmer Holdings, Inc. attached here:  Complaint

The updated handbook includes additional information in areas such as implant sizing, patient selection and contraindications, as well as significant updates to the techniques used in reaming, use of the trial implant, and acetabular implantation.  The updated handbook also indicates additonal resources for surgical training on their website.

Click here to see our evaluation of the changes between the old and new Durom Surgical Technique Handbook.

During the third quarter, the Company recorded a provision of $35 million for known and anticipated claims related to the Durom Cup. This brings the total provision for Durom related claims to $104 million. As previously disclosed our estimate for these claims is limited to revisions associated with surgeries that predate the 2008 temporary U.S. suspension and which also occurred within two years of the original surgery date.

To see more on Zimmer’s third quarter earnings, see the link provided below.

http://seekingalpha.com/article/168233-zimmer-holdings-inc-q3-2009-earnings-call-transcript?page=1

“‘We had failures with it, and we didn’t think it was a good design,’ said Dorr.  He thinks the design of the cup, which flairs out compared with a traditional hemispheric shape, can prevent bone in-growth integral to a long-term fix.   More recently, Dorr said he reviewed changes Zimmer made to the implant and would use the modified version of the cup if it gets approved for market. Dorr said the modified cup is more hemispheric and conventional in design, and he expects it to be phased in.

Zimmer spokesman Brad Bishop denied the product Dorr reviewed is a modified version of the Durom cup.  Rather, he said in an e-mail that Zimmer is developing another metal-on-metal cup for hip replacement that it’s planning to launch the second half of this year.  ‘This is a new design that is an addition to our product portfolio and is not an updated version of the Durom product,’ Bishop said in the e-mail.”

Since the problems with the Durom cup become widely known last year, many surgeons and patients have abandoned the device, despite Zimmer’s assurances that the device itself is not to blame for its apparent inability to achieve bony ingrowth.  Perhaps as a result of its Durom-related troubles, Zimmer has seen a decrease in its marketshare for orthopedic devices, and it will be interesting to see whether a new metal-on-metal hip implant design from the company will inspire confidence – or skepticism – from consumers. 

You can read the rest of Mr. Schroeder’s article here: http://www.journalgazette.net/article/20090608/BIZ/306089936