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M. Brandon Smith
M. Brandon Smith
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NexGen CR-Flex Knee Replacement By Zimmer

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Knee Replacements
Knees are a crucial component in daily movement. That is why people often look to knee replacement when they experience knee problems. Not all knee replacements, however, are successful. In fact, recent concerns about the higher-than-normal failure rate of NexGen CR-Flex Knee replacements (Porous Femoral component in particular) have prompted many to question the use of the knee device in patients. So how long has this been an issue?

Problems With Devices
In July 2010, as denoted by The New York Times, Senator Charles E. Grassley, requested that Zimmer Inc., the manufacturer of the NexGen CR Flex knee device, disclose its method of tracking the performance of orthopaedic devices after an outside consultant raised concerns about the perceived premature failure of the CR-Flex knee device. Senator Grassley also asked for a list of the safety concerns raised by the Zimmer Inc. consultant, Dr. Richard Berger.

Dr. Berger was far from being sold on the knee devices. Dr. Berger, after reviewing 108 cases of the NexGen CR-Flex Porous Femoral component, he questioned the device failures found in patients who received the NexGen CR-Flex Knee after he worked to design tools and artificial joints for Zimmer Inc. According to the report by Dr. Berger, he and Dr. Della Valle revised 9 out of 108 (8.3%) patients for the femoral loosening and pain. Dr. Berger also found that 39 patients (36%) showed evidence of radiographic loosening and that "[loosening and revision were not related to the surgeon, approach or patient type." Dr. Berger has subsequently issued a statement recommending that this particular knee device and component should not be used in any patients. The details of this statement and report by Dr. Berger are found here so you can read and interpret the results for yourself as we do not want to "mislead" or inappropriately cause any "alarmist fear mongering" about his findings in this regard. For what it is worth, Zimmer, by and through their national counsel believe: "Dr. Berger’s results are highly atypical…" and cite the Australian Orthopaedic Association National Join Replacement Registry 2010 Annual report (Adeleaide AOA; 2010; Table KT30, page 123) and The Swedish Knee Arthroplasty Register, Annual Report 2010 (page 30) for their position in this regard.

Zimmer’s national counsel, via the same cease and desist letter above, have also recently informed our office that in follow up to Senator Grassley’s inquiry:

"Zimmer cooperated fully with the inquiry, emphasizing its rigorous quality handling programs and product compliant handling, in general, and in its handling of the failures reported by one surgeon cited in The New York Times article, in particular. Zimmer can confirm that, following the meetings with Senator Grassley’s Committee staff, the Company has received notice that it has satisfactorily responded to all of the Committee’s requests pertaining to its complaint handling systems and the facts and circumstances of the specific complaints under review."

Despite these positions:

There have also been side effects reported with the NexGen CR-Flex (Porous Femoral component). Some of those side effects include:

· Knee stiffness

· Infection

· Thrombophlebitis, or the swelling of a vein caused by a blood clot

· Heart attack

· Stroke

· Nerve damage

Additionally indications of a loose knee device involve:

· Knee stiffness

· Knee pain

· Decreased range of motion in the joint

· Difficulty applying weight to the knee

Conclusion
While many knee replacements can be helpful (including those in the Zimmer NexGen family of implants), there still remain some patients that have not had successful outcomes as denoted in Dr. Berger’s report. In fact, a knee replacement that doesn’t work properly can create additional problems, but not all may be directly related to a defective or flawed product. If you have experienced problems from an NexGen CR-Flex knee replacement you may be able to receive compensation for your lost wages, medical bills and pain and suffering if it is determined you have a viable legal claim. It is critical to investigate your individual situation and determine your legal rights should you deciden to do so.

Disclaimer-After receiving a cease and desist letter from Zimmer’s national counsel, I feel it is necessary to encourage everyone to read the studies and information on this topic and educate oneself on these and related matters. In blogging about these issues, we are in no way trying to defame or mislead consumer, patients and healthcare professionals about the Zimmer NexGen CR Flex knee implant or its family of NexGen products. We are also not trying to it convey medical advice in this or any other blog post. If you have specific questions about your knee implant or any medical condition you might have, see your doctor.

1 Comment

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  1. Kathleen says:
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    I have a zimmer total knee replacement in January of 2004 and it gives me pain and swelling always…