DePuy Hip Implant Recall/Withdrawal
More hip implant problems, this time with Johnson & Johnson’s DePuy Orthopaedics division (click here for Stryker and Zimmer hip implant issues).
Contrary to the good corporate responsibility of Boston Scientific for their quickly recalled defibrillators, DePuy seems to have taken their sweet time with their ASR hip implants, in addition to trying (and failing) to direct public misinformation on the issue.
First the background: the DePuy ASR hip implant is used for hip resurfacing (which is apparently not an issue), and more traditional hip replacement, which is at issue. The device is a metal-on-metal ball and socket, which can cause metal debris early in the life of the implant. That metal debris causes inflammation, and can lead to damaged muscles and soft tissue. The end result is that a very expensive and painful replacement surgery intended to last about 15 years ends up needing revision within two or three years.
Use of the device in the United States started in 2005. Since 2008, the FDA has received approximately 300 complaints (most people don’t complain to the FDA, so this indicates that the problem is much larger) from patients or their doctors about the early failure of the device.
Here’s where DePuy and Johnson & Johnson try to hide the ball from consumers. The product is more heavily used in Australia, and it was withdrawn from the Australian market in December of 2009—three to four months ago. A few months ago, the public was informed that DePuy would be phasing out the ASR hip implant here in the U.S. because of “slowing sales.” Indeed, last month DePuy’s worldwide vice president for regulatory affairs stated that “With declining sales of this particular product in its market segment, we are focusing on newer technologies.” So, according to the manufacturer, there was no safety issue. This "phasing out" seems to me to be diction-wrangling in order to avoid a technical recall, with its incumbent bad publicity.
But, with two years of reports of device failures, the experience of the Australian market, and DePuy’s own statements now indicate that the ASR has significant problems, and the failure rate directly impacts patient safety. The March 6 letter from DePuy states that the device has a higher failure rate when used on “certain types of patients,” which include those of short stature (often women) and people with certain bone weaknesses. This very statement seems to encourage doctors to stop using it. I wouldn't be surprised if DePuy is offering surgeons a refund (or perhaps DePuy credit) on returned ASR hip implants.
Add to this the fact that there is no information for consumers about the hip replacement problems anywhere on DePuy’s website or Johnson & Johnson’s website, and it is clear that the manufacturers are simply trying to avoid their responsibilities. The "phasing out" should have come sooner (at least at the same time as the Australian "withdrawal" from the market), and the manufacturer should have confessed its problems early, instead of lying to the public about “slowing sales.”
If you have a questions about a potential hip replacement lawsuit, call 800-553-8082 or go online for an internet consultation.
Comments
Although the DePuy ASR hip replacement system was used in only 5% of the hip replacement operations performed in Ireland, this is a worrying time for anybody unsure of whether they have a faulty implant. The Health & Safety Executive are currently trying to identify which patients received a DePuy ASR hip replacement system and will be contacting them.
Posted by: DePuy Compensation | October 25, 2010 2:48 AM
I've had a hip replacement in the Feb 2008 with the Depuy Pinnacle metal on metal implant. It has been causing major pain and problems ambulating since Jan 2010. I know the ASR unit has been recalled, s there any info on the Pinnacle unit. It too is metal on metal and seems to be causing the same symptoms as the ASR implant? Also, is there a statute of limitations on these, I've heard a three yr time frame?
Posted by: Patti Apicella | October 26, 2010 4:28 PM
Highly interesting facts on the ‘DePuy Kick-Backs for Surgeons’, but that is not all, it comes even worst for us as victims of the entire nightmare ‘hip replacement gone bad’. Wow, and now they start blaming us victims that we have caused the injuries?
1. My right hip was replaced using one of the DePuy devices 2 days before Christmas 2008.
2. For the first 3 months after surgery I was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain.
3. Once I was ordered to walk on full weight, I was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when I walk only very short distances. Now, almost 2 years after surgery, many times severe pain kicks in when I just sit or lie down.
My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year.
4. The last time I saw my surgeon was a little over one year post-surgery. Again, I told him how severe my pains still were.
5. During this past spring/summer I tried to see my surgeon again. Mainly because I was suffering more and more. Unfortunately, due to my long tern ‘Leave of Absence’ I had lost my job and all my benefits including health insurance. My surgeon’s front office told me over the phone that I would have to pay a fee of $160 just to see the doctor as an uninsured person. I thought that that was odd because my surgeon and office knew that I never had recovered from all the post-op pains.
6. Just a short time ago I learned about the recalls and class-action lawsuits on the DePuy devices. Well, it took 4 phone calls and leaving messages with my surgeon’s office. Now, they finally returned my 4th call, and informed me that my hip replacement is a DuPuy device. Not without to mention that my hip replacement might not a DePuy device under the recall……Can you imagine a statement like that? To a patient who cannot sleep for more than an hour at a time because of severe pain in the area where hip was replaced?
After that statement of my surgeon’s office, I am not just questioning the possibly illegal $114 million in kick backs to surgeons, furthermore I am questioning if surgeons are still paid by DePuy Orthopedics. Now, only to put up a ‘first line of defense’ against patients so they don’t participate in law suits.
Worst comes worst:
I was told that DePuy is trying to get patients to sign medical release papers from hospitals. Supposedly, they claim that they would examine their bad devices. But I have also heard that investigators found out already that DePuy is destroying these devices in fact. All in order to get rid of evidence needed for class action law suits and upcoming trials.
My personal situation and circumstances make me almost angry. I apologize for that, but meanwhile and gathering a lot of information, who knows whether it is just DePuy hip replacements on recall, or is it all of their hip replacement devices? My severe pain is constant and severe. It is no fun to be unable to sleep for more than a couple of hours at a time, and that since almost 2 years. Having lost job, health insurance, and all the other benefits crippled me to a point that I had to file for disability.
Will there be justice done to victims one day?
Regards,
Juergen Schaberick
Posted by: Juergen Schaberick | November 4, 2010 10:00 AM
I had a hip replacement and have had intermittent pain in my thigh-i think it's a dup J & J device but can't get any answers. It was "installed" by Kaiser Permanente in Denver, CO
Posted by: jan | November 20, 2010 2:39 PM
ALL Pinnacles should be recalled. I'm getting ticked that folks are only referring to the metal on metal Pinnacles! My Pinnacle is a Polyethylene on Ceramic & has dislocated 3 times in a 5-yr time frame! ALL PINNACLES NEED TO BE RECALLED!!!
Posted by: Lisa C. | January 23, 2011 11:04 PM
I keep reading that the DePuy Pinnacle is a metal on metal. Excuse me, but I beg to differ! I have a Pinnacle Acetabular Cup Sector II & mine is Polyethylene on Ceramic & it has dislocated 3 times! ALL PINNACLES ARE DEFECTIVE & SHOULD BE RECALLED!!!
Posted by: Lisa C. | January 25, 2011 11:04 PM
Yes in 2001 I recieved a total hip on the left side the hip was the "DEPUY S-ROM SYSTEM W/ ZTT 2 PINNACLE ACETUBULAR SHELL 54MM POLY-DIAL LINER AND A S-ROM Co-Cr-Mo FEMORAL HEAD 28mm" I have had nothing but a nightmare since 2002 with heavy doses of pain medication for years not to mention "SSI FOR BEING DISABLED" Do to my hip pain and my lack of mobility. N ow my question is becouse of the pinnacle shell and the COBALT HEAD is this a MOM system or becouse of the poly-dial liner is it considered a crom system. Also becouse of the faulty shell "ZTT IS A PINNACLE SHELL WITH A COATING BUT STILL A PINNACLE SHELL" The shell REF:55-7154 THE HEAD REF:52-2028 and the POLY-DIAL ref:87-3558. All of this on a S-ROM stem does anyone know if this is still considered a Metal-on-Metal SYSTEM. Also can you tell me if this is still considered a PINNACLE ACETABULAR SYSTEM. Thank You STEVE
Posted by: STEVE CRAWFORD | March 7, 2011 4:08 PM
Having to undergo hip replacement surgery can be challenging and painful enough especially for elderly persons without the need for another surgery because the hip replacement device malfunctioned or should have been better designed.
Posted by: ASR Recall Lawsuit | December 24, 2011 11:01 AM