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Depuy Attune Tibial Loosening

How many need to be reported before the company takes action? Customers have noticed and even worse, competitors have noticed and are using it against us in the field. Wake up people!!

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Why don't one of you Depuy reps **** that whistle? This whistleblower case could be huge. There has to be emails that implicate someone in marketing or a sales manager. **** that whistle. You will make more money in a whistleblower suit than you'll ever make at Depuy.

Look deeper....why else would big distributors and long time Depuy guys leave if they didn't sense something was coming down the pike? They have too much business in place and leaving would be stupid. Unless they know there is a bigtime Attune lawsuit coming. There is no other reason why so many long-timers would leave.

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Did they have a moral compass during the ASR situation? Why would they handle it any differently now?

Why don't one of you Depuy reps **** that whistle? This whistleblower case could be huge. There has to be emails that implicate someone in marketing or a sales manager. **** that whistle. You will make more money in a whistleblower suit than you'll ever make at Depuy.

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Almost 350 responses on this thread. Nothing has changed though. JNJ and Depuy put their heads in the sand and go about their day. Surgeons know it. All the reps know it but nothing has changed. Has it got worse? Maybe. I see Attune's pulled out each month. Sometimes weekly. I pulled up MAUDE this morning and the numbers are startling. Just in the last 30 days there are 321 reports on Attune. This is one of them.

DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 7 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAYBack to Search Results
Catalog Number 150600007
Device Problem Failure to Adhere or Bond
Event Date 07/18/2017
Event Type Injury
Event Description

Complaint description: the patient was revised to address loosening of the tibial component at the cement to implant interface. Depuy cement was used. It was reported that the tibial base subsequently failed due to mechanical loosening, during the revision the tibial base was found to have debonded at the implant-cement interface. The patient suffered injury, pain and disfigurement. Doi: (b)(6) 2015; dor: (b)(6) 2017; (right knee).

Don't forget that these are just the incidents that have been reported. I know for a fact that not all of the failures in my territory have been reported.

Does Depuy and JNJ have any moral compass?

Did they have a moral compass during the ASR situation? Why would they handle it any differently now?

post

Almost 350 responses on this thread. Nothing has changed though. JNJ and Depuy put their heads in the sand and go about their day. Surgeons know it. All the reps know it but nothing has changed. Has it got worse? Maybe. I see Attune's pulled out each month. Sometimes weekly. I pulled up MAUDE this morning and the numbers are startling. Just in the last 30 days there are 321 reports on Attune. This is one of them.

DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 7 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAYBack to Search Results
Catalog Number 150600007
Device Problem Failure to Adhere or Bond
Event Date 07/18/2017
Event Type Injury
Event Description

Complaint description: the patient was revised to address loosening of the tibial component at the cement to implant interface. Depuy cement was used. It was reported that the tibial base subsequently failed due to mechanical loosening, during the revision the tibial base was found to have debonded at the implant-cement interface. The patient suffered injury, pain and disfigurement. Doi: (b)(6) 2015; dor: (b)(6) 2017; (right knee).

Don't forget that these are just the incidents that have been reported. I know for a fact that not all of the failures in my territory have been reported.

Does Depuy and JNJ have any moral compass?

when is the fda going to do something about this

post

Almost 350 responses on this thread. Nothing has changed though. JNJ and Depuy put their heads in the sand and go about their day. Surgeons know it. All the reps know it but nothing has changed. Has it got worse? Maybe. I see Attune's pulled out each month. Sometimes weekly. I pulled up MAUDE this morning and the numbers are startling. Just in the last 30 days there are 321 reports on Attune. This is one of them.

DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 7 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAYBack to Search Results
Catalog Number 150600007
Device Problem Failure to Adhere or Bond
Event Date 07/18/2017
Event Type Injury
Event Description

Complaint description: the patient was revised to address loosening of the tibial component at the cement to implant interface. Depuy cement was used. It was reported that the tibial base subsequently failed due to mechanical loosening, during the revision the tibial base was found to have debonded at the implant-cement interface. The patient suffered injury, pain and disfigurement. Doi: (b)(6) 2015; dor: (b)(6) 2017; (right knee).

Don't forget that these are just the incidents that have been reported. I know for a fact that not all of the failures in my territory have been reported.

Does Depuy and JNJ have any moral compass?

post

ASR all over again. If every major manufacturer reports in the same way (they do) and similar rates of compliance (they are) and one company (DePuy with Attune) is significantly higher (alarmingly) ...then what is the the problem?

Answer: Depuy's Attune baseplate desig

But this goes against the study that Depuy recently released (of their own data) saying that patients treated with Attune had a shorter hospital length of stay when compared to competitive systems. You can start laughing now.

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Reps and companies are required to report. Healthcare professionals and consumer reporting is voluntary. This still doesn't mean that the companies you mentioned are actually reporting these issues. They could very well turn a blind eye more than Depuy does.

ASR all over again. If every major manufacturer reports in the same way (they do) and similar rates of compliance (they are) and one company (DePuy with Attune) is significantly higher (alarmingly) ...then what is the the problem?

Answer: Depuy's Attune baseplate desig

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So is the S taking the place of the regular Attune? If so, is this cutting down on loosening issues or too early to tell?

Could any of this be a result of the cement manufacturer as these loosening issues are known to happen with all devices, not just Attune?

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Before we go there, is it a fair observation that other companies like Stryker and Zimmer aren't reporting the loosening issues with their systems? MAUDE reporting is voluntary so if a Stryker or Zimmer rep forgets to send the report in then no harm. Even better, these problems are never really problems because no one sees them.

Reps and companies are required to report. Healthcare professionals and consumer reporting is voluntary. This still doesn't mean that the companies you mentioned are actually reporting these issues. They could very well turn a blind eye more than Depuy does.

post

So is the S taking the place of the regular Attune? If so, is this cutting down on loosening issues or too early to tell?

Before we go there, is it a fair observation that other companies like Stryker and Zimmer aren't reporting the loosening issues with their systems? MAUDE reporting is voluntary so if a Stryker or Zimmer rep forgets to send the report in then no harm. Even better, these problems are never really problems because no one sees them.

post

And I bet the rep was talking about the fancy S Plus as the regular Attune fell off that bone.

So is the S taking the place of the regular Attune? If so, is this cutting down on loosening issues or too early to tell?

post

these failures are poor surgical technique nothing else

Are you from Depuy marketing? When you say something like this, the sales reps in the field have to take the shots from customers when they hear you are attacking their surgical proficiency. It is also sounds naive. I haven't seen even close to the amount of revisions with competing systems. Attune is like 4 to 1 in revisions to the others based on what I see in my territory.

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so these surgeons forgot how to implant devices all of a sudden the same time a new implant is put on the market

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2 more "clean as a whistle" Attunes out yesterday!

these failures are poor surgical technique nothing else

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