Stryker Hip Replacement Recalls Affecting More than 500,000
Posted on September 13th, 2012 by Zane Cagle
Stryker Issues Field Safety Notice
In April of 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals that acknowledged reports of heavy metal contamination. Stryker than issued a recall of devices in Canada, followed by a U.S. voluntary recall of the same Rejuvenate and ABGII hip replacement systems.
Stryker’s Rejuvenate System that features a chrome cobalt neck and titanium stem is marketed to patients in need of a primary total hip arthroplasty or replacement.
The US Drug Watchdog is calling US metal on metal hip implant disaster the biggest medical device failure in U.S history and they are convinced that there are literally hundreds of thousands of US citizens who are recipients of a metal on metal hip implant that has failed or will fail prematurely. According to the New York Times on December 27, 2011, “The so-called metal-on-metal hips, in which a device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more, as artificial joints normally do”.
The US Drug Watchdog says, “There are 500,000 US citizens with metal on metal hip implants, and we fear a failure rate of 50%. Our goal is to identify at least 250,000 plus US recipients of metal on metal hip implants to the best possible attorneys, because we will not stand by as hundreds of thousands of US citizens get left on the curb holding the bag for a problem that should not be theirs”.
The Stryker Rejuvenate hip implant is different from other hip replacement devices as it is not a metal-on metal hip replacement device. Instead, the Rejuvenate hip replacement device uses a ceramic component and was meant as an alternative to the metal-on-metal devices. The Stryker Rejuvenate hip replacement systems were marketed to younger patients as a modular hip replacement system as the components were custom made to fit each patient better. This customization was supposed to fit patients better and result in longer-lasting hip replacement that offered better range of motion.
Stryker Hip Problems:
Some patients have reported developing metallosis after having the Stryker Rejuvenate hip device implanted. It was initially believed that patients could not develop metallosis because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design. However, the Styker hip device does have a metal neck piece that can, under some conditions rub against a metal stem causing metallic debris to come loose.
Metallois is an adverse tissue reaction to heave metal in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tremors, dissolution of the bone, DNA changes and chromosomal aberrations. While most hip implants are expected to last 15-20 years, the Stryker Rejuvenate hips are failing in less than five years.
Styker is responding to concerns about the Rejuvenate failure rate by alleging that patients did not properly undergo rehabilitation following surgery or by blaming doctors’ implantation techniques. In a publication of Product Correction Bulletin (04/25/12) Stryker officials stated, “Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the PH of the tissue surrounding the implant”. However, that same month Stryker issued the urgent Safety Alert defining teh potential hazards of its Rejuvenate Modular System as follows:
* Excessive metal debries and/or ion generation- “fretting and/or corrioson at or about the modular
At The Cagle Law Firm, we realize that hip replacement surgery can be a painful and expensive procedure. Often the patients may experience a great deal of pain when these Stryker hip replacements fail. As well, the surgery to remove said implants and replace with a different hip replacement system can be costly. Often, these Stryker hip replacements fail or will fail in the next couple of years, thus if you have a Stryker hip replacement, you should get more information. If you have a Stryker hip replacement and you are having difficulties, you do not have to bear the burden of the medial costs and damages that the faulty hip replacement has caused. Call an experienced faulty hip replacement attorney today to get the information that you need. Call Zane T. Cagle at The Cagle Law Firm for your free consultation (314) 276-1681.