Guest guest Posted September 27, 2004 Report Share Posted September 27, 2004 Hi Alice- There was another notice sent out/posted today- Lorie Implant Recall Information With utmost commitment to industry-leading reliability, Advanced BionicsR is introducing additional manufacturing processes to screen out a recently discovered potential cause of a device failure for the HiRes 90KR cochlear implant. We have identified a few devices that contain residual moisture from the manufacturing process. In one case, the implanted device stopped functioning as result of moisture. To ensure that the additional test measures apply to all unimplanted devices, Advanced Bionics will recall all cochlear implants currently in stock at clinics. This action assures a higher industry standard for manufacturing and reliability. The HiRes 90K implant is highly reliable, with a cumulative survival rate (the standard measure of medical device reliability) of over 99% at 12 months, including devices removed for medical reasons. As the data suggest, cochlear implants (as well as other implanted medical devices) can and sometimes do fail prematurely. If a cochlear implant user (or parent of a cochlear implant user) has reason to believe that the cochlear implant is not functioning properly, the user should troubleshoot the system with new cables, back-up headpiece and back-up processor if possible. If these changes do not result in proper functioning of the device, the user should contact his or her implant center to have the system assessed. Symptoms of a device failure are obvious and may include continuous intermittent sound or no sound at all. The recall of unimplanted devices does not affect the more than 16,000 people who already have our cochlear implants. All models of our technology, including the CLARION 1.0, CLARION 1.2, CLARION CII Bionic Ear and HiRes 90K implants, remain safe, reliable and robust and present no hazard or danger to patients. We are sending letters to all of our cochlear implant users to inform them about the above information. If you have questions, please call Advanced Bionics' implant information line directly or through a relay operator at 877-454-5038 (Hours: Monday - Friday, 5 am to 5 pm PST). Corporate Headquarters Advanced Bionics Corporation 12740 San Road Sylmar, California 91342 U.S.A. Email : info@... Tel: +1 661-362-1400 Tel: +1 800-678-2575 TTY: +1 800-678-3575 Fax: +1 661-362-1500 European Headquarters Advanced Bionics SARL 76 rue de Battenheim 68170 Rixheim France Tel: +33 (0)3-89-65-98-00 Fax: +33 (0)3-89-65-50-05 Email: europe@... Web: www.bionicear-europe.com Asia-Pacific & Latin America Headquarters Advanced Bionics 25129 Rye Canyon Loop Valencia, California 91355 U.S.A Tel : +1 661-362-1400 Tel: +1 800-678-2575 TTY: +1 800-678-3575 Fax: +1 661-362-1500 Email: asiapacific@... Advanced Bionics Corporation Mann Biomedical Park 25129 Rye Canyon Loop Valencia, CA 91355 USA Phone: (+1) 661-362-1400 Fax: (+1) 661-362-1500 Phone: (+1) 800-678-2575 TDD: (+1) 800-678-3575 Email: hear@... www.bionicear.com If you would like to be removed from this email list: Reply to this message with the word UNSUBSCRIBE in the message body. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 27, 2004 Report Share Posted September 27, 2004 Lori, Thanks for the update. Alice > Hi Alice- > > There was another notice sent out/posted today- > > Lorie > > Implant Recall Information > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 28, 2004 Report Share Posted September 28, 2004 Hi Debra Thanks for sharing. What CEO was fired? I must have missed something some where Thanks Kim > As I tried earlier to say this is not a brand war, it is something that happened to a device and was brought to the publics' attention, however if you think ONE device failure led to a voluntary recall of outstanding devices you are not being realistic! Everyone is certain their implant is the best, and that is the way you should feel. It is a manmade device and subject to failures...did they say they found mildew in the unopened cases? Not that I read! Yes, this may involve devices manufactured a couple of years ago and implanted between then and obviously scheduled for use in the future, as we just read. > > It is so interesting that the two main manufactures of ci are having problems and only making changes when absolutely necessary. I am not Martha and certainly don't want to share a bunk with her, but the recent purchase of AB by Boston Scientific...and then a recall and firing of a recently acquired CEO, not looking good. Of course it was MY CEO that jumped ship when the DOJ got too close and now can't hide problems at his new home. > > This is a very emotional issue because these little devices gave us hearing, some for the first time ever heard loved ones call our names or heard a baby's first cries. I missed my daughter's name called at college graduation because my miracle failed, it happened and WOW it is hard to deal with but I knew going into the surgery is was a man made device...just like said, look at what precious Annika is sharing because she CAN hear TODAY and tomorrow they will deal with tomorrow. > > We should all empathize with the anxious, no matter the brand or the problem they have because without us as implantees...they would not continue to research and improve this wonderful device. > > Debra > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 28, 2004 Report Share Posted September 28, 2004 Debra says " We should all empathize with the anxious, no matter the brand or the problem they have... " and I say Amen! *---* *---* *---* *---* *---* My mind not only wanders, it sometimes leaves completely. & Gimlet (Guide Dawggie) Portland, Oregon N24C 3G 8/2000 Hookup rlclark77@... http://home.comcast.net/~rlclark77/ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 28, 2004 Report Share Posted September 28, 2004 Yes.. this is where I stand too. As I said in the e mail yesterday - we don't want to turn this into a brand war. We are all interested in the CI for the same reason - hearing. Careful consideration of what is said is important so that we have an adult respect for each other and can remain friends. This is a difficult subject to discuss and we all need to think before we push the send button. Let's see if we can handle it in a dignified manner please or we'll just end the discussion here. Just a gentle reminder, folks. Alice > > Debra says " We should all empathize with the anxious, no matter > the brand or the problem they have... " and I say Amen! & Gimlet (Guide Dawggie) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 28, 2004 Report Share Posted September 28, 2004 Ok Alice. I am sad that this started out as a heads up, then empathy was shown, which was questioned. It was not necessary. I do not feel good that its happening to the Clarion users present and future. It could happen to Med El and Nucleus too. Nuff said. *---* *---* *---* *---* *---* Always and never are two words you should always remember never to use. & Gimlet (Guide Dawggie) Portland, Oregon N24C 3G 8/2000 Hookup rlclark77@... http://home.comcast.net/~rlclark77/ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 5, 2004 Report Share Posted October 5, 2004 My surgery went as scheduled on the 27th of September. It went well and has healed up nice without scarring. I will have my first mapping on the 15th of this month. by Steve Puson. My wife had a stroke so please remember her in your prayers. Larry Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 11, 2011 Report Share Posted April 11, 2011 Had my hip done in 2008. I am on the recall list but things - x-rays look good, I am having problems with pain at different times. Sometimes while I am lying down and others while shopping or ant time at all. Some days little and others way more. The pain shoots down from the hip. Anyone having this problem??? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 12, 2011 Report Share Posted April 12, 2011 yes, i still have the same problem although i had it done  one year ago. the surgery was lateral approach,cemented, metal to polythelene. x rays are ok,three doctors said that the operation is technically correct. the pain starts after i sit or drive for say half an hour or more then stand.i feel it in the knee and the thigh outside muscle and at the hip joint front and continues for one minute and few steps. if pain exists i limb . i am continuing on PT as per the doctors recommendations to strengtthen the muscle .  Mustafa Attili . ________________________________ From: <thub321@...> Joint Replacement Sent: Mon, April 11, 2011 2:16:15 PM Subject: Recall  Had my hip done in 2008. I am on the recall list but things - x-rays look good, I am having problems with pain at different times. Sometimes while I am lying down and others while shopping or ant time at all. Some days little and others way more. The pain shoots down from the hip. Anyone having this problem??? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 12, 2011 Report Share Posted April 12, 2011 Hi , I did not have a recalled implant, but just had surgery to revise a Bio Met M2M implant that was painful, very. The metallosis testing I had done revealed a very high level of both cobalt and chromium in my blood stream, which led to surgery for revision. That along with pain that was undiagnosed by any other cause. My surgeon found that the acetabular component was completely loose...i.e. had no bone growth whatsoever between my pelvis and the cup. IT was so loose he was able to remove it with a forceps. This was after 18 months of pain and fairly limited ability to resume normal walking, biking etc. It is very much worth your time and energy to pursue some testing, even if you are not having pain. Im only 53 and the thought of living with such elevated metal levels for an extended period was frightening...considering that we still don't know how our bodies metabolize such elements... IF you want more information, or if I can be of any help at all please let me know. I also have some contacts into the legal world of " implant recall " issues... Celaine Bouma-Prediger Quote Link to comment Share on other sites More sharing options...
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