OTISMED RECALL

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I really hope this is true. Im chomping at the bit to convert all the Otismed business. Accolade and Trident recalls and now this. Just need some retrieval studies on X3 showing the result of residual free radicals and I would be complete.
 




Nothing is being re-called, moron. FDA has asked OtisMed to re-submit as a class 2 device with the FDA, & until the ppwk is in order, has told Otis to suspend production of cutting blocks.

Don't worry, it will have 510K shortly & will continue to totally kick the crap out of signature, tru-fit, etc...etc...
 


Anonymous said:
I really hope this is true. Im chomping at the bit to convert all the Otismed business. Accolade and Trident recalls and now this. Just need some retrieval studies on X3 showing the result of residual free radicals and I would be complete.
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Trident was a voluntary re-call from Stryker.

You really think you can convert hip business of off a recall on +16 v40 taper heads?

Please. You sound like you're pretty new to the field. I'm sure you're excited to have landed a high-payinhg job in a competitive industry, but if you think you are going to be able to barge in & take OtisMed business with a wet-behind-the-ears cutting block that is hardly custom to the patient & requires a full leg CT scan, then you are sorely mistaken.

Depuy is asking 1900.00 for their "custom block" that does little more than restore mechanical alignment....laughable. Biomet is asking 1300.00 for a block that only sets pin-holes for their standard set & also is limited to mechanical alignment.

Tell me....just what on earth are you being innovative with here?
 




Anonymous said:
I really hope this is true. Im chomping at the bit to convert all the Otismed business. Accolade and Trident recalls and now this. Just need some retrieval studies on X3 showing the result of residual free radicals and I would be complete.
Click to expand...
LMAO.

You aren't converting anything. Signature, Tru-fit, Wright or S&N(snicker) don't have a product that can compete with Otismed.
 




Looking at what signature & tru-fit bring to the table, you really don't have much of a product either. You think Otis is going to lose MS over the FDA haggling a ppwk re-file for class 2?

Please.

Otis is still the standard here. Regardless of FDA-mandated manufactoring freeze. I beg you to compare your product with Otis. It blows your weak "custom knee" out of the water.
 


Lets see here. Otismed is the end all be all and no other companies compare. Is that how you sell your joints as well? Other companies have taken the flaws of Otismed and improved on them. I know with ours you can align on the mechanical or Anatomical axis, surgeon can customize the plan or use what the engineers sugest, Surgeon can use MRI or CT scan, use blocks that have metal cutting guide or a pin guide, and can sterilize just like standard instruments. How is the Otismed block better than that? Otismed may have been the first to market but they are definately not the best out there. You say no one will convert business but I doubt surgeons are going to want to postpone thier surgeries until you get all this figured out. They can either use the technology they believe in with a different company( these are patients who have probably been told they were getting custom knee) or use traditional instruments with or without Nav. Bottom line is that you don't have a product until you get all your regulatory issues cleared up. In the mean time I will be seeing how may surgeons are willing to wait around for that.
 


You guys at Stryker must have some strong KoolAid. Yes, I know they told you to forget everything you know about conventional knee replacement but please don't get carried away here. The facts are there have not been any randomized prospective studies comparing the Otis method with conventional knee replacement to prove wether it is any better in the short term or long term. Yes I know anecdotally all the patients are doing great and the rehab is wonderful (as it would be for most good surgeons who balance a knee) but lets just say at best it is an alternative to conventional knee replacements.

I hope some of you smart guys deep down in your heart of hearts at least allow for the possibility that it may in fact have negative long term implications. I dont want to get into all the inherent issues with the way Otis has you put in a knee, that would be to long a discussion. I would personally not have it done to me or any of my loved ones. Sure it can turn out fine particularly in the short run, but the long term I am scared of.
 


I would love to see a Stryker rep use common sense and not just spit out what they are told. Metal on Metal hips are bad, well except for in our resurfacing. The problem with squeking hips isnt a problem and is with all ceramic on ceramic, ignore the papers and 09 academy presentation showing that squeking is directly related our components. Crossfire poly is the greatest and there are no issues with free radicals in our annealed poly, but just in case we will anneal it a 3rd time and call it X3. The accolade is the greatest stem, we just use the data from Biomet's stem. So when they blindly say that Otismed is the best system just know they can't help it, its habit.
 


Otis has a randomized, double-blinded study that will be released at AAHKS in Novemeber. The data that I have been hearing is very, very good from a patient scoring perspective. Otis has been steadily gaining market-share, & that just does not happen with a poor product. It provides value to the hospital, from an OR efficiency standpoint....it provides value to the surgeon, from a practice marketing standpoint.....& it provides value to the patient, from a performance standpoint.

There is a reason why every company is scrambling to get their version to market. I expect 510K to delay a bit while the wonderful beaurocratic govt agency we know as the FDA gets everything together, & Otis will continue to help Stryker Triathlon gain market share in TKAs.

It really comes down to what your surgeon believes in. I have found that a lot of younger guys that have a background in sports medicine really understand, & believe in the concept of kinematic alignment. If you can get hospital administration to get past the initial cost of the blocks & see the inherent value of time economy, there are good selling points to be made there, as well.

It is certainly a lot of work to get it approved for use at a particular facility, but the vast majority of what I am hearing back from those who have, have had very positive results.

Can we avoid a Depuy-Stryker-Zimmer-Biomet pissing match in this thread, please? It becomes so tedious & childish, it would appear that most of you reps are still in your 20s, trying to shout at your competition, when you should be talking with your surgeons.
 




Anonymous said:
you do know that otis works with biomet vanguard right?
Click to expand...

My understanding is that Oris has broken away from its relationship with Biomet & that Stryker is close to purchasing OtisMed & that is why Biomet has been working very hard to bring the singature knee system to market. IMO, The Biomet Vanguard is probably the 2nd best TKA system on the market right now, behind Stryker Triathlon. I have a high volume surgeon that has used different designs from all 4 of the major comapnies, & in his opinion, it goes:

1. Stryker Triathlon
2. Biomet Vanguard
3. Depuy Sigma
4. Zimmer Nexgen

His only real complaint with the Vanguard has to do with instrumentation & the funky locking mechanism on the tibia. I should be fair & say that the surgeon I am discussing is a big believer in single radius femoral design as a characteristic that allows for better mid flexion stability, as well as preventing paradoxal anterior translation of the femoral component.
 




"Can we avoid a Depuy-Stryker-Zimmer-Biomet pissing match in this thread, please? It becomes so tedious & childish, it would appear that most of you reps are still in your 20s, trying to shout at your competition, when you should be talking with your surgeons."

I get so tired of reps trying to discredit people because they are younger. Thats the same attitude as the democrats saying people are racist who oppose Obama. When you can't address:

Metal on Metal hips are bad, well except for in our resurfacing. The problem with squeking hips isnt a problem and is with all ceramic on ceramic, ignore the papers and 09 academy presentation showing that squeking is directly related our components. Crossfire poly is the greatest and there are no issues with free radicals in our annealed poly, but just in case we will anneal it a 3rd time and call it X3. The accolade is the greatest stem, we just use the data from Biomet's stem
or
The facts are there have not been any randomized prospective studies comparing the Otis method with conventional knee replacement to prove wether it is any better in the short term or long term. Yes I know anecdotally all the patients are doing great and the rehab is wonderful (as it would be for most good surgeons who balance a knee) but lets just say at best it is an alternative to conventional knee replacements.

and your only defense is:

Otis is still the standard here. Regardless of FDA-mandated manufactoring freeze. I beg you to compare your product with Otis. It blows your weak "custom knee" out of the water

The data that I have been hearing is very, very good from a patient scoring perspective. Otis has been steadily gaining market-share, & that just does not happen with a poor product.

I have a high volume surgeon that has used different designs from all 4 of the major comapnies, & in his opinion, it goes:




Then turn to the age defense.
 



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