Ranking Member of United States Senate Committee’s Look into Zimmer NexGen Knee Problems

Zimmer Holdings, Inc.
It is common for companies to hire consultants. Consultants can provide critical advice and suggestions. However, the advice and suggestions are useless if they are ignored. So what does this have to do with Zimmer Holdings, Inc.?

Advice of Zimmer’s Consultants
Senator Charles Grassley, the Ranking Member of the United States Senate Committee on Finance, revealed some disturbing details about Zimmer’s response to the concerns of its long-time consultant, Dr. Richard Berger. According to the New York Times, one of the surgeons with whom Zimmer had a financial relationship, Dr. Richard Berger, raised concerns to the company a few years ago about the premature failure of a certain Zimmer knee implant, the NexGen CR-Flex. In addition, a second Zimmer consultant, alerted other doctors that Zimmer’s Durom hip device was failing a few years after they were implanted in patients. And the two doctors were not the only ones who were worried. Others also voiced concerns about the device failures. Zimmer responded that it was the surgeons’ technique, not the devices that were flawed.

Details of Zimmer’s Relationship with Berger
There are, however, a few details about Berger’s relationship with Zimmer which should be revealed. Berger had a financial relationship with Zimmer spanning a decade. He was paid more than eight million during that time. Berger also previously supported Zimmer’s knee product. He only changed his opinion of the product as time passed and he saw negative results over time.

Grassley’s Questions for Zimmer
Senator Grassley posed a number of questions for Zimmer. Those questions are listed below.

1) What process does Zimmer have in place to respond to allegations and concerns

raised by its consultants or contractors regarding the safety of one of its products?

2) Since January 2008, how many Zimmer consultants or contractors have raised

safety concerns or problems regarding Zimmer’s products? For each product for

which concerns or problems were reported, please include the following:

a. The name and affiliation of the consultant or contractor and whether or not

s/he is still a Zimmer consultant;

b. The name of the product;

c. The specific concern(s) or problem(s) reported to Zimmer;

d. Whether or not the reports of safety concerns or problems led to product

changes/modifications; and

e. Whether or not the reports of safety concerns or problems led to product

discontinuation.

3) Of the safety concerns or problems identified since January 2008, how many were

refuted by Zimmer?

4) Although not required to track the long-term performance of its devices, does

Zimmer voluntarily collect data on the performance of its hip and knee devices

and other implantable devices? If so, how is that data collected? If not, has

Zimmer considered putting in place a process for tracking and reviewing the

performance of its devices?

Conclusion
Companies should listen to negative details about their products whether those details come from consultants or elsewhere. Failing to do so is unethical and could have legal consequences. When a concern is voiced, a company should at the very least do its due diligence and investigate. Doingso may prevent a recall and ensure the health and safety of countless people.

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Product Identification Notice: In any of our web pages referring to Zimmer NexGen products, these pages are intended to provide information about and are referring to the same Zimmer products that were identified by Dr. Berger in his presentation and study entitled "The High Failure Rate of a High-Flex Total Knee Arthroplasty Design," and were written about in the NY Times article titled "Surgeon vs. Knee Maker: Who’s Rejecting Whom?," and that are reported in the FDA MAUDE database, where reports involving the Zimmer NexGen CR Flex Cementless or Porous Femoral component can be found and also those products associated with aseptic loosening of the Zimmer MIS Tibial Component that led certain doctors to discontinue its use, and to recommend discontinued use of this product in primary TKA until the etiology of the high early failure rate of this implant is determined. See prospective studies comparing the results of the Zimmer MIS Tibial Component using conventional and minimally invasive exposures as well as comparing fixation with different types of bone cement as described in Early Aseptic Loosening With a Precoated Low-Profile Tibial Component A Case Series. Not all Zimmer NexGen products are involved in our investigations and lawsuits.