Analysis Of Stryker Rejuvenate Recall From Hip Defect Lawyers
In July 2012 Stryker issued a voluntary recall of its popular Rejuvenate and ABG II hips following a stream of documented problems with the devices. For a hip prosthetic device that was intended to have a working life of 10-20 years, patients began experiencing high rates of complications and device failures that necessitated monitoring or a replacement of the device with a procedure known as a hip revision surgery.
The area of the hip that is believed to be responsible for this complication is known as the ‘modular neck joint’ commonly referred to the ball and socket joint where the components from the device meet. The actual connection of the artificial joint is composed of metal-on-metal parts that have the propensity to wear on one another during normal use causing bits of the metal components to wear of and become embedded in the surrounding tissue.
In the words of Stryker, the Rejuvenate and ABG IG hip systems have the “potential for fretting and/or corrosion at or about the modular neck junction, which may result in adverse local tissue reactions manifesting in pain and/or swelling.”
For many patients the pain associated with this device and the complications associated with the ‘fretting’ has necessitated a second --- and far more invasive surgical procedure knows as a hip revision surgery. While performing a hip revision surgery, the device is removed and replaced with a different type of artificial hip. Unfortunately, the removal of the original device is painful and has the potential for serious complications such as the fracture of the femur due to the design of the stems in the Stryker products.
As a result of these apparent design flaws, many people with these devices has initiated lawsuits against Stryker based on:
• Design flaws
• Failure to warn of complications
• Deceptive marketing
• Inadequate pre-market testing
• Negligence in design and manufacturing techniques
Rosenfeld Injury Lawyers is actively pursuing Stryker Rejuvenate and ABG II hip defect cases and is moving forward with the prosecution of these cases. If you are the recipient of one of these devices we encourage you to speak to one of our Stryker hip recall attorneys now—even if you are not presently experiencing any symptoms—so we can discuss the most recent updates and your particular situation.
Our attorneys are committed to obtaining the most favorable recovery for each of our clients and we are prepared to litigate these cases for the long run. In anticipation of a protracted battle, our team has retained experts in the fields of: medical device design, FDA approval process, metal poisoning, rehabilitation and economics to ensure that our clients future needs are provided for.
We welcome the opportunity to discuss your case with you without any cost or obligation on your end. Give us a call at (888) 424-5757 or visit or websites.
Unlike typical hip implant systems, which include a one piece neck andstem, Stryker’s Rejuvenate and ABG II systems include several neck andstem components. The systems were designed to give surgeons greaterflexibility by offering them more anatomically correct implant componentsthat could be custom-fitted to patients.CONCERNOVER THE REJUVENATE & ABG II MODULAR-NECK HIP STEMSSupposedly offers stabilityand minimal bone stressABG II SYSTEM THE REJUVENATE HIPMarketed to younger patientswho were promised longerlasting devices that offered abetter range of motionHIP IMPLANT COMPONENTNeck16(8 right, 8 left)10 616NeckStem
Stryker’s implants are made using Chromium andCobalt, two Heavy Metal Compounds. When a devicefails, these metal compounds can release metal ionsand metal fragments into surrounding tissues andblood stream, causing pain or inflammation of thetissue. More severe cases can cause internal bleeding,gastrointestinal issues, increased risk of cancer andeven patient death.THERE’S NO CURE FOR HEAVY METAL POISONINGCOMPLICATIONSHeavy Metal Poisoning (Metallosis)
In faulty implants, the various parts in the imp,lant canloosen and subtly push into the underlying bonestructure. This causes Osteolysis, where the calcium inthe bone fluids starts to get drained off. The calcium isbroken down and re-absorbed by the body through theblood stream. Then your bones loose density andbecome more brittle resulting into cracked bones,fractures, pain in the hip, difficulty walking or difficultysitting.YOUR BONES CAN LOOSE DENSITYAND BECOME MORE BRITTLEDamaged Bone Structure (Osteolysis)
MIGHT NEED REVISION SURGERYTissue destruction can be caused by metal ions andmetal fragements breaking off into the surroundingtissue. The tissue dies inside the body, but isn’t alwayssuccessfully broken down by body. Often time thedead tissue has to be removed by a surgeon duringrevision surgery.Tissue Destruction (Necrolysis)
Blood thickening is caused by primarily cobalt poisoning,which can result from metallosis. In a person withpolycythemia vera, the red blood cell count in the bloodgets inflated. This causes the blood to thicken andbecome sluggish.PARALYSIS, LOSS OF BALANCE AND EVEN STROKEHEADACHES , DIZZINESS AND FATIGUEThickening of blood (Polycythemia Vera)
Heavy metals can cause or increase risk of cancer inthe number of different ways. Both cobalt andchromium can interfere with cell’s ability to repairDNA, resulting in a higher likelihood of mutations. Oneparticularly dangerous effect of chromium is thepossibility of lymphocyte infiltrationCAN TURN INTO A TUMORInflitration of Lymphocytes
Stryker submits the stryker Rejuvenate ModularHip system’s 501(k) to the FDAStryker submits the Stryker ABG II Modular-NeckStem’s 501(k) to the FDAStryker begins marketing the Rejuvenate ModularPrimary Hip System to doctors and medical facilitiesStryker issues a voluntary recall of all Rejuvenateand ABG II devices sold in the United States. Avoluntary recall means it was issued by themanufacturer, though most recalls are also donewith the help and cooperation of the FDA.The FDA approves the application, based on a determinationthat the Stryker Rejuvenate was substantially similar to anexisting product.The FDA approves the application, based on adetermination that the Stryker ABG II was substantiallysimilar to an existing product.Stryker issues an “ Urgent Safety Alert” informingdoctors of the potential side effects of using theRejuvenate system.April 14, 2008AugustFebruary 2010July 6, 2012June 3, 2008October, 2009April 2012THE STRTYKER FAILURE TIMELINE
Recalled Stryker Hip Products?IMAGINGYour surgeon may choose to performcertain imaging on your hip, including X-rays, MRIs, or Ultrasound. These forms ofdiagnostic imaging may help your surgeonin evaluating your hip.BLOOD TESTTo check for dangerously highheavy metal (chromium, cobalt &titanium) ion levels that may havebecome absorbed by the body.HIP REVISIONHip revision surgery may be necessary in some patients with adverse localtissue reaction or ongoing pain. A revision surgery requires the replacementof the metal hip with a ceramic-on-metal modular junction replacement.Stryker hip revision surgeries can be difficult for the patient bacause thestem components of a hip implant are driven deep into the patient’s femur--requiring a quite a bit of force to remove. some revisions may result in femurfractures as the hardware is removed.SPEAK TO AN ATTORNEYAs a recipient of a defective medical device, you may be entitled topursue a claim for monetary damages from the manufacturer. The lawhas specific time constraints for filling a lawsuit. You may wish to talk toa Stryker hip recall lawyer immediately to protects your rights.
THANK YOUTalk with our attorneys to learn more about theStryker hip recall and your legal rights: (888) 424-5757www.rosenfeldinjurylawyers.com www.strykerhipfaq.com|