Failure of Zimmer’s Trabecular Metal

“We believe Trabecular Metal has the potential to give us opportunities in the fusion and non-fusion spinal categories that other competitors cannot match.”. Unfortunately, this story was not as successful as Zimmer had hoped it to be.
The primary focus of this is on Spine, but the failures of TM are far reaching including issues with bond strength, loosening, & instability. You can find examples of this is the various product recalls that Zimmer has done fairly recently in fact.

You can contact me here for any questions. https://amedicablog.wordpress.com/contact/

 

Lol. Zimmer will fuck with Dr.Bal as long as it takes him to drive into a lake. After he tried to screw them over they still talk about him to this day and I bet they are dragging this out until Amedica is delisted and worth pennies. All just to mess with Sonny.... lol.

 

"Disclosure: I currently hold a long position in $AMDA. All research materials are linked to their source for verification. Anything that is not quoted is my opinion based on the research provided."

Your research uses other people's opionions on anonymous forums back 2011 to peddle this BS as a desperate attempt to pump up investor hope and have a great stock price. Read your study. You say it yourself, your opionion based on research, your research based on anonymous forums. You lost ALOT of money is what all this screams. Lol. Send Dr.Bal a note from us here thanking him for tanking this company to a point where he has Zero negotiating power at the table. We will walk and walk until the only thing left is the patents.

"In 2011, another anonymous poster calls out an acquisition of Amedica by Zimmer citing licensing Si3n4 as one way to bolster their spine revenue while also acquiring next generation hip & knee implants. Another poster believes this is a good fit for Zimmer if Si3N4 proved to be as good as claimed. So far results have been very good"

 

unlike TM Si3N4 is actually clinically proven!!! Links on my blog!

 

Nobody even defending TM shows there is a huge problem with it. Anymore pending recalls?

 

You clearly have not been in revisions where TM has had to be revised.... nearly destroyed a femur getting an avn rod out, cups are completely grown in and tm tibs on the Nexgen keep going and going and going.

Amazing product that works a little too well sometimes.

 

Don't need the real world when evidence shows that TM is an issue. Look at my blog then tell me otherwise, you will see that my research is spot on. Dare You.

 

That's what I thought. Zimmer desperately needs Si3N4.

 

Subtle...haha

Anyone with any experience in orthopedics as it relates to the traditional use of TM in arthroplasty knows that deeming it a "failure" is asinine (i.e. a decade plus of ubiquitously positive usage in incredibly complex reconstructive situations, demonstrated in-growth and osteoconductivity, modulus of elasticity much closer to cancellous bone--limiting stress shielding, .98 CoF against cancellous bone, consistent porosity for revascularization, in addition to the favorable biocompatible material properties of tantalum and dozens of peer-reviewed support, to the point where even acetabular cups not fully seated demonstrated up to 5mm polar voids filled with bony in-growth...likewise, anecdotally I've been in surgery where INFECTED TM cups took 2+ hours to remove with a zimmer explant system, not to mention witnessed first-hand this technology changing the lives of patients in revision cases who had no hope otherwise of regaining mobility)

Also, quick comment on silicon nitride: good for bearing surface? Sure, assuming it doesn't produce nephrotoxic or hepatotoxic, or early aseptic loosening due to particulate debris, proven over massive tribology cycles.

Is it a superior porous material? Meh. The inconsistent pore structure (100 micrometers (um) -700um) obviates the "70% interconnectivity" of pores because revascularization has been proven to require a porosity consistently 300um+. This equates to "on-growth" vs. "in-growth". Compare this to TM which has 80% porosity and precisely engineered 440um pores...does on-growth work? Sure! You could implant a spoon and get on growth if it's loaded appropriately...but is it far superior? Doubtful...hardly worthy of needing Si3N4 "desperately", unless of course your tech platform is the aforementioned spoon...

Sincerely,

a concerned engineer.

 

Subtle...haha

Anyone with any experience in orthopedics as it relates to the traditional use of TM in arthroplasty knows that deeming it a "failure" is asinine (i.e. a decade plus of ubiquitously positive usage in incredibly complex reconstructive situations, demonstrated in-growth and osteoconductivity, modulus of elasticity much closer to cancellous bone--limiting stress shielding, .98 CoF against cancellous bone, consistent porosity for revascularization, in addition to the favorable biocompatible material properties of tantalum and dozens of peer-reviewed support, to the point where even acetabular cups not fully seated demonstrated up to 5mm polar voids filled with bony in-growth...likewise, anecdotally I've been in surgery where INFECTED TM cups took 2+ hours to remove with a zimmer explant system, not to mention witnessed first-hand this technology changing the lives of patients in revision cases who had no hope otherwise of regaining mobility)

Also, quick comment on silicon nitride: good for bearing surface? Sure, assuming it doesn't produce nephrotoxic or hepatotoxic, or early aseptic loosening due to particulate debris, proven over massive tribology cycles.

Is it a superior porous material? Meh. The inconsistent pore structure (100 micrometers (um) -700um) obviates the "70% interconnectivity" of pores because revascularization has been proven to require a porosity consistently 300um+. This equates to "on-growth" vs. "in-growth". Compare this to TM which has 80% porosity and precisely engineered 440um pores...does on-growth work? Sure! You could implant a spoon and get on growth if it's loaded appropriately...but is it far superior? Doubtful...hardly worthy of needing Si3N4 "desperately", unless of course your tech platform is the aforementioned spoon...

Sincerely,

a concerned engineer.

 

Lol. Even Smith and Nephews Redapt blows TM out of the water. It's an old technology. It's time has gone. Sorry you don't know your competition.

 

Hi again,

I don't work in the orthopedic industry, I work in VC. Additionally, I'm pointing out material characteristics based on peer-reviewed criteria for in-vivo success and survivorship, not who owns a marketplace (of which S&N is still little brother to the big boys) Also, concerning my prior point now applied to redapt:

From S&N website:

CONCELOC◊ Advanced Porous Titanium

• Customized, patent pending porous structure technology
• Material composition: Titanium Alloy (Ti-6Al-4V)
• Porosity: Up to 80%
• Pore size: 202μm to 934μm

Key words: "up to 80%" implies inconsistent porosity, and "202 um to 934um" implies non-controlled pore size, which yields less consistent vascularization per Karageorgiou et al (https://www.ncbi.nlm.nih.gov/pubmed/15860204)

S&N has been playing material catch up since they went all in on Oxinium...glad you think the Redapt is great, and I have no doubt it works. The dirty secret in ortho is that it ALL works relative to success rates for other surgical disciplines, so you must know thy materials to make the best decisions on technologies. Or you can just point to Redapt's years and years of clinical history...Oh wait...

 

Hi again,

I don't work in the orthopedic industry, I work in VC. Additionally, I'm pointing out material characteristics based on peer-reviewed criteria for in-vivo success and survivorship, not who owns a marketplace (of which S&N is still little brother to the big boys) Also, concerning my prior point now applied to redapt:

From S&N website:

CONCELOC◊ Advanced Porous Titanium

• Customized, patent pending porous structure technology
• Material composition: Titanium Alloy (Ti-6Al-4V)
• Porosity: Up to 80%
• Pore size: 202μm to 934μm

Key words: "up to 80%" implies inconsistent porosity, and "202 um to 934um" implies non-controlled pore size, which yields less consistent vascularization per Karageorgiou et al (https://www.ncbi.nlm.nih.gov/pubmed/15860204)

S&N has been playing material catch up since they went all in on Oxinium...glad you think the Redapt is great, and I have no doubt it works. The dirty secret in ortho is that it ALL works relative to success rates for other surgical disciplines, so you must know thy materials to make the best decisions on technologies. Or you can just point to Redapt's years and years of clinical history...Oh wait...

 

Redapt is all 3D printed and is actually really good say our Zimmer surgeons that started using it. We have lost some business recently in phoenix and the surgeons seem to really like it in the operating room. Never saw an Amedica product at my accounts. We all know data takes time, but from what I have seen in real life situations lends me to believe TM is becoming a thing of the past and the next gen of implants will take its place.

 

Totally agree with you, but for a different reason--the cost and difficulty in producing TM will push it out the door, not lack of performance.

Thanks for the reply--my point wasn't to point out Redapt is less than, just that it takes more than just yelling a technology's days are numbered to convince someone like myself outside the industry--understanding and defending material implications would help with taking claims seriously in this regard. On the plus side, I've heard S&N still pays 1099 reps a reasonable commission, which is a rarity these days!

 

Get ready for your much needed overhaul of implants from Amedica! M/A coming soon!! Zimmer will be relevant and getting market share soon in spine and hips, knees not to far away also! Si3N4 will bring Zimmer into the future.

 

Genuine post:

Amedica is awaiting clearance of a porous fusion device not unlike TM Ardis C. It incoporated Amedica's porous SiNi technology like a typical implant but requires bonegraft.

I believe Zimmer signed the letter of intent to develop a Sini version of Ardis. Clearance of a porous Valeo implant would clear the way for clearance of a Si3N4 version of Ardis.

http://bit.ly/2zlVNxE

 

Everyone here hates Sonny Bal. He has even testified as a witness against us before. I know of only one Dr who uses Amedica and he runs a POD (silently) and makes more then Amedica does per case (and annually lol). He only uses Amedica because of the crazy %, he could care less about the technology. If Amedica is still doing these deals just to get surgeons on board it makes sense they have barely any revenue coming in. This douchebag has no idea how things work in this industry.

 

This^^. SB is a backstabber who is always looking out for his pockets. This Amedica clown on Zimmer board probably lost his life savings at amedicas failure of an IPO and desperate for anything now. Actually quite comical that Bal got investors to drink the koolaid!