Attune Tibia issue

Send me the link. I can't find this

 

Many Maude reports include this statement by Depuy. I'm not sure how to link them.

 

Just do your own DD. Google FDA MAUDE and then search DePuy and Attune. You will see the statement in most December reports but fewer in March. I guess they realized they were being too sweet to the lawyers. That won't save us though.

 

But what does the statement mean?

 

It means what it says. What are you missing?

 

"The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. (b)(4) has been undertaken to investigate further. The analyses and investigations eventually led to a new product development project, which will enhance fixation and make the product more robust to surgical technique per (b)(4). Depuy considers the investigation closed at this time."

 

The investigation? Other than the Maude response did they notify the FDA of an investigation. B4?

 

It all sounds like the Project Alpha that was supposed to remove the groove from the ASR cup.

Find out in 2007 that your smallest cup needs to be implanted at 26 degrees to give the effect of a 45 degree inclination. Don't tell a single customer.

Buy ads in JBJS saying how great your registry data is.

Recall the product in 2010 after tens of thousands of people have been exposed to a known problem and had their lives screwed up.

Same playbook ten years later?

 

You need to get real here. If folks need a simple tibia revision that is not the same as having metallosis so this is nowhere near as bad.

 

Only a simple tibia revision. How would you feel if you were forced to go through another surgery and the rehab bc a company covered this up? Not to mention the defective product is continued to be used. Sad world we live in

 

Of all the stupid statements I have read on CP over the years this one takes the cake.

 

It is a higher up for sure, most of them don't even know what an OR looks like. To them, "just a tibia revision" means another sale and more profit. We get to look our surgeons in the eyes every time a baseplate comes out clean. That's reality.

 

Not a simple tibia revision for the few I have seen. They had to pull the femurs off also, and those did not come off clean, lots of bone loss... How many were and continue to be revised with a femoral explant also because there were/are no other options available? Full knee revisions are no joke, especially in a knee marketed for younger active patients.

 

For the "few that you have seen". How does this indicate a major problem? I'm sure you've seen a few of all types of knees.

 

Not within a year of implantation and first time I've seen a clean cemented implant pulled out like it was teflon lined. I have seen 10 plus year old knees get loose and come out fairly clean but there is always some sort of cement mantle left on the implant. Fresh cemented knees should NEVER come loose like this. You obviously have no time in any operating room or any experience with knee revisions. Any other questions?

 

Exactly

 

^^^^^^^ well said.
There is a problem.

 

You would never enter into any revision without being armed to revise the whole knee. There is not such thing as a simple tibial revision. 99% of all knee revisions I have seen over the last 20 years that were due to tibial loosening, malposition or subsidence had both femur and tibia revised. This is even if the knee was less than 3 years old.

 

What was the new coating put on the attune tibial baseplate?