Depuy Pinnacle Recall

I was talking to my fellow Zimmer rep and he was asking me if I knew anything about an imminent recall on the Pinnacle cup system. Any info on this?

Originally Posted by Anonymous

I was talking to my fellow Zimmer rep and he was asking me if I knew anything about an imminent recall on the Pinnacle cup system. Any info on this?

You two must be experts in damage control when it comes to recalls...

I'm in a case right now, where we are revising a pinnacle shell MOM. Metalosis present. Not a lot of synovitis.

Originally Posted by Anonymous

I'm in a case right now, where we are revising a pinnacle shell MOM. Metalosis present. Not a lot of synovitis.

Get off the computer and help your surgeon.

Originally Posted by Anonymous

Get off the computer and help your surgeon.

with what, picking out a bunch of dead tissue? Been there, its not pretty.

Originally Posted by Anonymous

Get off the computer and help your surgeon.

After the surgeon removed all of the necrotic soft tissue that he could from around this failed Pinnacle MOM 36, I helped him implant our revision shell with a 40mm head/poly liner combination. The hope is that the soft tissues don't continue to deteriorate & that we won't see this patient back for a constrained liner at age ~55.

Being that it took a ton of time to dig out all of the crap from around the joint capsule, I had plenty of time to type that short 2 sentence post from my iPad, while the Depuy rep stammered around the subject of recent acetabular failures and liner dis-associations, related to Pinnacle Cup.

"My surgeon" was very thankful for the help I provided in this particular case.

Hopefully, Depuy monitors this a little more closely, and acts more appropriately than they did in the instance of ASR, which the company waited a year after Australia pulled it, to declare(with the FDA poking a pitchfork at its back) a global recall.

I don't see a full pinnacle recall happening any time soon, if at all. Depuy waited until the last minute to pull ASR back....more than a full year after Australia yanked it, as another poster said above. Everything at this point is still anecdotal, until the FDA sends a warning letter. Regardless, there do appear to be on-going issues with Depuy's MOM offering....not just associated with ASR. As for liner dis-associations, thats easily blamed on surgical technique, and shouldn't be a major factor in all of this. I do suspect that Depuy will end up having to yank MOM completely within a few years...but don't expect the company to be proactive about it.

Just revised a Pinnacle cup for liner disassociation. Had never seen that before. Surgeon tried to re-impact the liner, as the patient was only 3-4 weeks post-op, but it wouldn't engage. Had to open a new liner and it seemed to pop in correctly. Strange.

Sounds like a bunch of zimmer reps who got a memo from corporate telling them to start trying to create an issue with pinnacle. If he just popped in another Poly why were you in the room

Originally Posted by Anonymous

Just revised a Pinnacle cup for liner disassociation. Had never seen that before. Surgeon tried to re-impact the liner, as the patient was only 3-4 weeks post-op, but it wouldn't engage. Had to open a new liner and it seemed to pop in correctly. Strange.

That explains double digit growth

The recall rate is very bad and your friend must ask any lawyer for more correct information
http://www.productliabilityinsight.c...asr-hip-recall

I heard it was a combination of Corail/Pinacle, they redesigned the proximal section of the Corail a couple of years back, and with the large MoM bearings the torque is transfering and causing proximal failure, with osteolytic failure. Looking like Corail is being brought into this too.

Originally Posted by Anonymous

I heard it was a combination of Corail/Pinacle, they redesigned the proximal section of the Corail a couple of years back, and with the large MoM bearings the torque is transfering and causing proximal failure, with osteolytic failure. Looking like Corail is being brought into this too.

no, they just redesigned the neck geometry to the Articuleze mini taper.

This is all just competitive reps trying to play off the fears from the ASR recall. They are trying to cast doubt on all the depuy hip products. The pinnacle is not going to be recalled and is a great product. There is no evidence to show that the pinnacle MOM is having any problems that all other MOM systems aren't having. I have seen revisions with Wright, Biomet, and a couple resurfacing devices for issues with metalosis, psuedo tumor, high ion levels, etc. So to sum it up, Yes ASR had issues and J&J is taking care of those patients, Any issues claimed to be about Pinnancle MOM are not specific to the pinnacle but are issues with all MOM devices. Just sell your products and stop trying to cloud the debate with unsubstantiated claims. This can always come back to bite you when the next rumor pops up about your product (Stryker squeky hips, Zimmer TB Nexgen, etc).

There is no evidence to show that the pinnacle MOM is having any problems that all other MOM systems aren't having.

Pinnacle MOM Liner Dissociations are happening all over.

So to sum it up, Yes ASR had issues and J&J is taking care of those patients

...after trying to sweep it under the rug for 4 years and moving as many customers as they could away from ASR unless that meant losing their hip business to Wright or Biomet. JNJ's biggest problem isn't that the ASR had a high failure rate...it's that they knew it, and lied to their customers about what was going on. $1B could just be the beginning.

Patients who were implanted with the defective device should be allowed to recover a full measure of damages. So if you are one of the unfortunate victims of this defective device, you may want to consider a Hip Recall Lawsuit to get the compensation you deserve. Please contact a hip recall lawyer that is experienced in handling defective hip implant cases to assist you and do this before you contact the manufacturer.


zimmer hip damages

no doubt a comment from a scum lawyer

The guy who broke the ASR issue in England reckons it is a a Corail pinnacle issue, not just a pinnacle one.

Just saw a post which said that anyone who mentioned corail was an idiot.
Tony Nargol, (he was one of the UK lead surgeons on ASR, so has far longer experience than pretty much any surgeon worldwide) is reporting:
40% of our ASR XL are between 4 and 7 and 66% of our Corail Pinnacle 36mm MoM hips between 3.1 and 7 ppb of cobalt.
Full story here:
http://www.hipresurfacingsite.com/Me...enu-id-77.html

It is very dishonest to use this to try and give corail a black eye. Corail has seen great long term survirvorship in multiple studies. Nowhere in this article did it state that he thinks there is an issue specific to corail. The article was addressing that elevated ions can be seen in not only resurfacing but THA with monobloc and modular metal on metal. This same thing could be said with other companies also.

It's a rumor; I don't believe there is really anything to it, either. I highly doubt Pinnacle will be recalled. The Australian (I think?) registry just announced their findings on multiple studies and records of the Pinnacle cup and found it had 97% survivorship at 10 years. It's going strong.

This is a really good question. As far as I know there is no recall issued or in sight for the Depuy Pinnacle Cup System. Many people think that a recall is inevitable because of many similarities with the ASR defective hip implants in terms of problems caused, but a recall is not based on similarities, it is based on test and facts. I hope that the company won't be blinded by greed and will issue a recall in the moment they find out some yet unknown critical fault.

What about the anecdotal reports coming from De Puy surgeons that they are revising Pinnacle Marathon liners for locking mechanism failure?

There are 229 MAUDE reports for January alone related to Pinnacle.

Sounds a great exchanging of ideas here. I think you should consult a better <a href:"http://www.rotlaw.com/depuy-pinnacle"> lawyer </a> to emphasize and explain to you what you should do for this case. It is very alarming to everybody what has the new technology has been defected to human being, though it help us but in other cases their were disadvantages engaging with it.

I recently heard rumor that Depuy is pulling the 40mm and 44mm Pinnacle liners off the market because of disassociation problems. Supposedly there was a conference call with the sales force a week or so back about the issue but I have not seen anything locally in terms of inventory being pulled or surgeons notified. Could just be rumor..... Or?

235 reports in June for Pinnacle showing up in MAUDE

Maude specifically states that it is not to be used in the way you are trying to use it. One revision can show up several times in Maude. Pinnacle has more than 1million implanted. It has great survivorship. It's time to start selling your systems and stop trying to add doubt to the pinnacle system.

My elderly mother had a pinnacle cup hip implant that failed and ruined her life and had to have it redone. Without going into all the details, I made the mistake of contacting DePuy to give them a chance to settle with mom for a relatively low price (which doesn't undo the tragedy). DePuy stalled me for 10 months and kept asking mom to sign medical release forms over and over (3 times for the same doctor and hospital) though I learned that this was just stalling: they only requested records from the hospital the first time. And DePuy would wait each time until the release forms would expire (90 days) so that mom would have to sign these again. DePuy is evil and vicious.

Now we are having to hire an attorney. Don't try to deal directly with DePuy. That is like dealing with the devil!