Conformis recall, has anyone else here been affected?

[Tiasabita]

Wow, @BusterBeans! Only a two week delay! Awesome!

 

[limpy1940]

Re-scheduled my surgery today to Nov 9, but, am not convinced that they have already chosen a remedy or that it is approved by FDA. Was told that they were ordering new devices be made and starting over, but would be using an alternative procedure for sterilization that they have used in the past. They never disclosed the lawsuit posted Sept 3:

SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action Against ConforMIS, Inc. and Certain Officers - CFMS
09/03/15 05:42 PM EDT
NEW YORK, NY / ACCESSWIRE / September 3, 2015 / Pomerantz LLP announces that a class action lawsuit has been filed against ConforMIS, Inc. ("ConforMIS" or the "Company")(NASDAQ: CFMS) and certain of its officers.' The class action, filed in United States District Court, District of Massachusetts, and docketed under 15-cv-13295, is on behalf of a class consisting of all persons or entities who purchased ConforMIS securities: (1) pursuant and/or traceable to the Company's Registration Statement and Prospectus (defined below) issued in connection with the Company's initial public offering on or about July 1, 2015 (the "IPO" or the "Offering"); and/or (2) on the open market between July 1, 2015 and August 28, 2015, both dates inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934 (the "Exchange Act") and the Securities Act of 1933 (the "Securities Act")...........

'The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies both in connection with its IPO and in subsequent filings with the SEC. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company's manufacturing processes were flawed; (ii) that as a result of the flaws in the Company's manufacturing process, a number of the Company's knee replacement product systems were defective; and (iii) as a result of the foregoing, ConforMIS's public statements were materially false and misleading at all relevant times."

Not sure what to think about all this at this point. Considering canceling and finding alternative. What do you think?

 

[PolarBear60]

They would be unlikely to discuss the lawsuit. Once those are underway, neither party tends to discuss them. In some cases, they may be forbidden from doing so.

I'm not sure FDA approval would be an issue with this problem. As I understand it, the implants were never faulty, but the packaging process turned out to not be completely sterile in some cases. The company, as a precaution, voluntarily recalled all devices.

Certainly, if you want to cancel with this product and seek another, that's up to you. You have to have confidence in both the surgeon and the implant. I'm completely unaffected by this recall, but I haven't seen anything in my admittedly superficial reading on the subject to raise my concerns about either the company or the implant. Indeed, I'm impressed by their cautionary approach once they identified a potential problem.


Jean

LTKR (Stryker Triathlon): 21 April 2015
Right Knee Arthroscopy: 25 July 2006
Left Knee Arthroscopy: 10 February 2005

 

[Tiasabita]

Hi! Congrats on getting a new date!

This class action suit seems to be for people who invested in the company or bought securities, if I'm seeing it correctly, not for patients. Although just trolling around online it seems there are quite a few law firms talking about ConforMIS. But I think law firms try to jump on any recall for anything just in case!

ConforMIS seems to be an honest company. This was a voluntary recall when there is no evidence that anyone has definitely been hurt by the water droplets on the instruments. So it seems they want to do the right thing. I would feel comfortable that the implants are good to go.

I hope to make contact with my doc this morning and get some more info as well!

 

[Celle]

@limpy1940 , I agree with the others. Don't dwell on the law suit. It has nothing to do with your surgery.

Conformis seems to me to have acted responsibly and pro-actively, in doing a voluntary recall before any problems occurred, apart from a small amount of water in the packaging. Apart from the delays, no patients were affected. No one had the implant with possibly faulty packaging inserted. The implants themselves were not faulty.
Conformis's quality control seems to have acted quickly and efficiently.

For you, it's a major inconvenience - but much better than having the implant used and then finding out there could have been a problem. For Conformis, it's a routine recall, to prevent the slight possibility of a future problem.

 

[Gojennygo]

@limpy1940 , I agree with the others. Don't dwell on the law suit. It has nothing to do with your surgery.

Conformis seems to me to have acted responsibly and pro-actively, in doing a voluntary recall before any problems occurred, apart from a small amount of water in the packaging. Apart from the delays, no patients were affected. No one had the implant with possibly faulty packaging inserted. The implants themselves were not faulty.
Conformis's quality control seems to have acted quickly and efficiently.

For you, it's a major inconvenience - but much better than having the implant used and then finding out there could have been a problem. For Conformis, it's a routine recall, to prevent the slight possibility of a future problem.

Hi @Celle

600 affected implants WERE installed, according to their press release. I am wondering if my RTKR was one of the affected units. And if there is no problem with those 600, it is aggravating that they pulled the 300 completed units, instead of re-sterilizing the tools.

inconvenience to those affected by the recall is an understatement.

The lack of communication from Conformis is extremely aggravating and unprofessional. Almost 3 weeks of having your entire life on hold, with no idea of when it will proceed is infuriating. My calm acceptance of this situation is deteriorating with each passing day.

Comformis, if you're reading this, for your next recall, you should be contacting your affected customers personally by letter or phone or email. To leave us and our physicians in the dark, is unacceptable.

 

[Jamie]

Comformis, if you're reading this, for your next recall, you should be contacting your affected customers personally by letter or phone or email. To leave us and our physicians in the dark, is unacceptable.

I know it seems like the company should do more, but the recall program has government-directed procedures they follow in cases like this and it is not required (nor is it probably even feasible) for the implant manufacturer to contact each patient impacted individually. The manufacturers contact the doctors and it is their responsibility to notify their patients and make other arrangements for the surgery. Some doctors will do a good job of this; others will not. The process is not perfect by any means.

 

[Tiasabita]

So @Gojennygo, I hate you haven't received a new date yet. You are definitely one of the more inconvenienced by this cuz you wanted to do all your 'suffering' at one time. And for others whose activity level is severely compromised, I feel awful for you. You all want and need to get this done!!

I did get a new date of November 19. The nurse would not use the word 'recall'. She said it wasn't really a recall, the company just wanted to be sure things were sterile after a couple of instruments had some water left on them after being sterilized. Whatever. I guess they gotta dumb it down and maybe the word 'recall' is just too scary! She verified the implant would be shipped back to ConforMIS and resterilized. Two months seems kinda long since I've seen a couple of posts of rescheduled dates in October and early November. The nurse said she had no idea why it was two months for me, just that the company told her my implant would be available for use on the 19th. I asked her to please call me if it came in earlier and she laughed and said that won't be happening. It did take 6 weeks to get the first one so maybe 8 weeks isn't too crazy considering the backlog.

I feel fortunate and know that I need to just shut up because I am still functional for the most part. I can work and ride my bike and still walk, albeit only about a mile. Sure, I've had to give up stuff I want to do but so many of you are in a worse place so my fingers and toes are crossed that everyone will soon have a new date and can get on with it!

 

[davep]

Had Conformis PKR on August 27th. I heard about the recall a few days ago. I asked my PT at my doctor's office about it. She said if something was wrong I would probably know by now. I asked if there was someone there with more definite information on whether my implant was on the recall list. I was referred to a person in the doctor's office. Asked for them to call me, waited to 2 days and called back about it --- still waiting. I then called Conformis and asked them, waited two days and called back. Again they said someone would call me back -- still waiting. Great service

 

[Gojennygo]

Had Conformis PKR on August 27th. I heard about the recall a few days ago. I asked my PT at my doctor's office about it. She said if something was wrong I would probably know by now. I asked if there was someone there with more definite information on whether my implant was on the recall list. I was referred to a person in the doctor's office. Asked for them to call me, waited to 2 days and called back about it --- still waiting. I then called Conformis and asked them, waited two days and called back. Again they said someone would call me back -- still waiting. Great service

As I stated earlier, Conformis should have and could have contacted us, their customers. The could have even sent a form letter to the affected patients. We get recall letters for our cars, for goodness sake! I am certain they have a database of their customers. It is annoying and frustrating to wait endlessly with no word.

 

[Jamie]

Jenny, did you not see my post above? The implant manufacturers follow procedures set up by the government. They do not maintain databases of patients receiving their implants. That would be a violation of your privacy and not a good idea at all to have any of your medical information in the hands of a private manufacturing company. Their "customers" are the surgeons and they are notified. I know it must seem to you like ConforMIS should have more direct involvement with you, but that's just not the way the companies and the government procedures are set up.

If you want to be put out with someone, make it your doctor. He is the one who could obtain additional information for you. He was notified of the recall. But frankly, what the nurse told Tiasabita is exactly what this recall is all about. It was a possible sterilization issue. The company was proactive in bringing back all the products for re-sterilization and reissue. At this point in the process it would seem to me your surgeon should be able to give you some expectation of a new surgery date.

 

[Gojennygo]

Hi @Jamie

Yes, I saw your post and I thank you for your input. I am fully aware of what the recall is about, my doctor called me and explained the sterilization problem when he had to cancel my surgery. And after researching and finding their press statement online. I notified this website with this thread. My issue is not with the recall, but with the lack of communication.

I actually do not want to be "put out" with anyone, but after having my life put on hold for 3 weeks, I am understandably upset about my situation. My doctor has communicated very well with me, I believe he is as frustrated as I am.

I disagree with you that the doctor is the customer of the replacement joints. He may order, install and recommend a joint, but I am the end user.

As for having my medical information in the hands of a private company, Conformis has my name, doctor's name, cat scans, measurements, and I am sure other identifying information in order to manufacture my custom replacement knee.

Here is a suggestion for Conformis: Conformis could have had a form letter made up explaining the details of what they are doing for the doctors to give to their patients. They probably won't do this to protect themselves legally, but since they put out a statement to their investors, they could have put out something for their consumers. I do not want to criticize without offering a solution.

I understand that this website is funded by and operated by a collective of the manufacturers of knee joints, so I get why you are so defensive of their practices. I know very little about any government regulations that manufacturers have to follow, beyond HIPAA laws.

I suppose by posting on here, we are providing the joint manufacturers a wealth of useful, personal information voluntarily. Age, dates of surgeries, medications given and for how long, etc. The price we the consumer is paying for the advice and fellowship we receive?

 

[Gojennygo]

I realize that my post above sounds cynical and somewhat negative. This waiting is getting me down big time. It is of the utmost importance to keep a positive attitude through out these events. Having no control, having my surgery cancelled, having all of my planning be wasted, being unable to make any plans for the next surgery, and on and on, ON TOP of recovering from my first TKR is pushing me to my limit.

I am dreading going through the pain again, more so each day as the first knee is finally, at 7 weeks tomorrow, starting to have less pain. I wanted to be further along before bad/icy weather arrives.

I am hoping to hear from my doctor tomorrow with a date for surgery. If and when that occurs, I will be able to work on my attitude adjustment.

 

[Josephine]

My issue is not with the recall, but with the lack of communication. My doctor has communicated very well with me, I believe he is as frustrated as I am.

Well, there y'go then! You surgeon 'communicated well' with you. What more information would you require? In a previous post I did also say

most manufacturers have problems such as these from time to time.

I disagree with you that the doctor is the customer of the replacement joints. He may order, install and recommend a joint, but I am the end user.

Actually, Jamie is correct. Sometimes some of this recall information is very technical and needs to be passed though an appropriately qualified person - i.e., the surgeon.

I understand that this website is funded by and operated by a collective of the manufacturers of knee joints, so I get why you are so defensive of their practices.

In no way is BoneSmart operated by a collective of manufacturers but a not for profit organisation which is owned by Richard Warner, recipient of two THRs who has no financial rewards from it and no medical background or connection, just a passionate desire to provide a patient advocacy site for similar individuals. Firms who come on board as sponsors do so on the explicit understating that they have no input on either website or forum and therefore do not direct or even influence the input of me or my staff. The Forum is also under the scrutiny of a board of directors who are very adamant about that too. You can read more a bout the structure of BoneSmart here The History of Bone Smart Forum.

I suppose by posting on here, we are providing the joint manufacturers a wealth of useful, personal information voluntarily. Age, dates of surgeries, medications given and for how long, etc. The price we the consumer is paying for the advice and fellowship we receive?

How? No-one can attribute your posts to a specific individual so such information would be sketchy to say the least. And yes, of course a person from a company might read the forum from time to time to see what's being said, same as they can on our Twitter or Facebook accounts. It is the internet after all and therefore freely accessible to anyone. I might also point out that you pay no membership fee to belong to this forum. You are more than welcome here for absolutely no 'price' whatsoever!

 

[Josephine]

I realize that my post above sounds cynical and somewhat negative. This waiting is getting me down big time.

Jenny, we do understand and we ARE in your corner. We have all been through JR surgery so can readily imagine your frustration and anxiety.

 

[kaw205]

I will be seeing my OS this Wednesday to discuss scheduling my next ConforMIS (RTKR).
I'll pick his brain regarding the recall.
PS- Knee #1 is doing great. Looking foreward to getting another ConforMIS!

 

[Lone Wolf]

Yeah...just heard my date was rescheduled from Oct 8th to December 16th...wow...long ways out...that much of a push out can really complicate life when you work and have to try and schedule leave...sigh! Very frustrating!!!!!!

 

[Lone Wolf]

Especially since having the surgery scheduled for 3 months now and now almost 3 months more...even if I get leave approved....I guess a back log is an understatement

 

[Lone Wolf]

This thread has gotten very quiet so I hope that means that a majority have their new dates if they were rescheduled...the countdown begins to knee #2

 

[kaw205]

I saw my OS last week and he said they are back in production.