Dr. Brooks Replies to the Smith & Nephew Law Suit July 24, 2013

[Pat Walter]

The press release today that reports
Nephew hip lawsuit has ruled that the Plaintiff’s claims of negligence and strict liability involving alleged quality control issues in the Birmingham Hip Resurfacing System may go forward, Bernstein Liebhard LLP reports.


was a concern to me.  I still believe hip resurfacing is still an excellent solution to hip replacement based on a lot of facts,  but this type of press causes a lot of fear and negative discussions.  I wrote to a handful of surgeons to make replies to the press release which is at the end of this post.

I am posting Dr. Brooks reply to the press release from July 24, 2013:

Hi Pat,
My take on this is that it is not an unexpected response to the generally higher than desired failure rate of MOM total hips. None of the doctors I know will primarily recommend a MOM THR anymore. A few short years ago these were very popular, mostly due to the fact that dislocations continue to plague THR, representing the single biggest reason for revision THR in the USA. Since dislocation goes down with bigger heads, and the biggest heads of all are with MOM hips, your average hip surgeon went for the biggest heads to avoid dislocation and used a MOM THR.
Unfortunately, as happens in technology development, there was an unanticipated problem. The junction between the head and stem of a THR (a "Morse taper"), is a cold weld designed back in the days of 28 and 32mm heads. Placing a very large MOM head, perhaps 50-58mm, exerted so much torque compared to the original 28 and 32mm heads that it overcame the design limits of the Morse taper, and micromotion with fretting and corrosion developed at this junction. This is not metal debris from the bearing (the ball in the socket), it's from the junction between the head and the neck of the MOM THR. Research has shown 10 times as much metal debris emanating from this junction as from the adjacent MOM bearing, where all the attention was directed!
Many MOM THR's were done around the world, and actually Smith and Nephew's did better than most, if not all, of the others. Nevertheless, it was not as good as it needed to be, so they recalled it. Now they recommend it only for use in femoral side revisions of their BHR, so long as ther are no concerns with the socket. It is worth noting that this is the only FDA-approved use of their big head MOM THR already.
So, it's a problem with MOM THR's that have modular junctions. In the 60's, the MOM THR's that McMinn sought to replicate as a resurfacing in the 90's, did not have modularity, so there was no Morse taper. The metal levels in these are more like resurfacing. Low and safe.

Now, what about resurfacing? Here, there is no modularity, no Morse taper, no concerns about fretting and corrosion. It's just the bearing. Here, bigger is better.
And the amazing thing is that registry data confirms the hypothesis: the failure rate of MOM THR's is worst in the bigger diameters (more torque, more fretting and corrosion at the taper junction), yet the reverse is true in resurfacing, where the bigger diameters do the best (better lubrication, less fussy socket positioning, less edge loading, more likely a male).
MOM THR and MOM resurfacing are totally different animals, and while I do not recommend MOM THR, I continue to recommend resurfacing as the best option in young healthy people, of adequate size, using a well-designed device, and done correctly.
Best regards,
Peter Brooks MD, FRCS(C)

 Smith & Nephew hip lawsuit has ruled that the Plaintiff’s claims of negligence and strict liability involving alleged quality control issues in the Birmingham Hip Resurfacing System may go forward, Bernstein Liebhard LLP reports. In an Order dated July 22nd, Judge Joan H. Lefkow of the U.S. District Court for the Northern District of Illinois rejected Smith & Nephew’s assertions that the claims were preempted by federal law. The Birmingham Hip Resurfacing System may be used with the optional metal liner component for the R3 Acetabular Hip Replacement System, which was the subject of a Smith & Nephew hip recall in June 2012.* (Tillman v. Smith & Nephew Inc., No. 1:12-cv-04977 (N.D. Ill.))

“We continue to hear from individuals who have suffered serious complications, allegedly due to Smith & Nephew hip replacements. We are encouraged by the decision in this case,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free Smith & Nephew hip lawsuit evaluations to patients who suffered serious complications, including metallosis and premature device failure, allegedly due to the recalled R3 metal liner component.

Smith & Nephew Hip Recall
The Smith & Nephew hip recall was announced in June 2012, due to the high failure rates associated with the optional metal liner component for the R3 Acetabular System. According to the Food & Drug Administration (FDA), the R3 metal liner is not cleared for use with the R3 Acetabular System, a total hip replacement system, but has been approved for use with the Birmingham Hip Resurfacing System.*

According to a report from Reuters, yearly revision rates among recipients of the recalled Smith & Nephew hip replacement device were above the rate Britain’s National Institute for Health and Clinical Evidence deems acceptable. Patients fitted with the device may be at risk for numerous complications, including infections, fractures and dislocations. However, Smith & Nephew has maintained that there is no evidence that the metal liner has caused metallosis, or increased metal debris in the body.**

Victims of serious complications allegedly associated with the Smith & Nephew hip recall may be entitled to compensation for their medical care, pain and suffering, and other damages. Additional information about filing a Smith & Nephew hip lawsuit is available at Bernstein Liebhard’s website. To arrange for a free, no obligation legal review of your case, please call 800-511-5092 today.

*fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm, FDA, June 1, 2012
**reuters.com/article/2012/06/01/us-smithnephew-hip-idUSBRE85010J20120601, Reuters, June 1, 2012

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

Bernstein Liebhard LLP
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New York, New York 10016
800-511-5092

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
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http://www.consumerinjurylawyers.com

[bestbob]

In reading what Pat has posted (reply from Dr. Brooks and a snipit of the lawsuit), it looks to me like 2 different topics are mentioned. I may be wrong, and input is welcomed.

1. Dr. Brooks comments speak specifically to MOM THR using larger heads, and to me does not see any similarity/concern to a BHResurfacing.

2. The lawsuit speaks to the optional metal liner component for the R3 Acetabular System for a BHResurfacing.

Based on the above 2 topics, the question I would ask is, was the optional metal liner component for the R3 Acetabular used or not in my surgery?

Am I missing something here, and welcome all comments.

Bob

[Lauren Lee]

bestbob, If I am reading other info online correctly there was a recall of this part a little over a year ago. That being said, I think it would be unlikely that that part would be used in recent surgeries. At least I hope that would be the case.

[B.I.L.L.]

Hmmmmm..... so the problem area on thr's isn't the bearing surface so much as it's where the seperate componets fit together.  Well thats something to think about aint it ?

[Pat Walter]

The problem area in almost all poorly done hip resurfacings is that the acetabular cup and/or femur component have not been placed at the proper angle causing edge wear.  It is the edge wear that causes the high metal ions.  All the more reason for using a really experienced surgeons that places components properly.   Here is Dr. Gross's paper on the Safe Zone for acetabular cup placement http://www.surfacehippy.info/pdf/hap-paul-award-dr-gross-2012.pdf

Even with the recalled ASR, the acetabular cup was not as deep as the BHR and caused edge wear and high metal ions.

It is very important to have the two bearing surfaces aligned properly to work as a good solid bearing. It is a mechanical problem that has to be resolved by physical placement of components in the body - which is a challenge due to the differences of all our bodies!

There is no recall of the BHR hip resurfacing components.  That is why I posted the article because I knew there would be a lot of discussion when the article hit the press.  I also asked several surgeons to comment.

Pat

[moe]

Could someone explain the term "cold weld" in Dr. Brooks reply?

[hernanu]

Could someone explain the term "cold weld" in Dr. Brooks reply?

Cold weld is a method of welding the exact same materials (even if they are compound alloys, like we deal with). The idea is to weld it without causing the metal to melt, so no heat is applied.

The possibilities for doing it are:

• High pressure.
• Pressure under a vacuum.
• Nano cold welding (new and improved)

The idea is to disrupt the metal to metal interphase enough to allow the two parts to merge at the seam.

This is done with the applied pressure, shattering the surface oxides and allowing the metals to flow into each other due to the pressure. The bond formed is strong, but there is significant deformation in the transverse direction.

The reason it's cold is because it's done at room temperature, with no heat or electricity being applied.

[moe]

Thanks for the reply Hern. I would have very little confidence in that method.