On July 6, 2012, the Food and Drug Administration announced that Stryker Orthopaedics had recalled its Rejuvenate and ABG II modular-neck hip replacement systems. The Stryker Rejuvenate and ABG II systems were both put on the market in 2009.
Unlike most hip implant systems which include a one-piece neck and stem called a monoblock design, Stryker Rejuvenate and ABG II systems include several different neck and stem components that are interchangeable. They were designed to give surgeons more flexibility by offering different sized components that could be more custom fitted for patients.
Stryker manufactured the stems using a titanium alloy blend that mixed titanium, molybdenum, zirconium and iron. Before the recall, Stryker claimed that this patented blend of metals resisted corrosion and fretting (when small particles of metal flake off of the implant and into the body).
The recall notice issued by Stryker stated that they were recalling these products “…due to the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.”
The complications that can occur to patients due to the implantation of these Stryker systems is metallosis (metal toxicity from grinding metal components), necrosis (premature tissue death), osteolysis (bone dissolution), pseudotumor formation and pain requiring revision surgery.
According to Stryker, your surgeon should consider performing a clinical examination, such as blood work and cross section imaging on all his or her patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether they are experiencing pain and/or swelling. Repeat follow-up examination, such as blood work and cross section imaging, should be considered even in the presence of normal initial findings.
If you had a Stryker Rejuvenate or ABG II system implanted or are unsure whether or not your hip replacement system is subject to the recall, you should contact your surgeon as soon as possible.
Stryker Hip Lawsuits
In addition to receiving the appropriate medical care, patients who have had these defective hips implanted may have legal recourse. Lawsuits are being filed against Stryker alleging that the company was negligent in failing to warn the public about the high rates of failure and failing to adequately test these products before releasing them on the market. The lawsuits also accuse the company of making fraudulent claims that the neck and stem systems in the Rejuvenate and ABG II systems were not subject to fretting and corrosion.
Here is the state of current litigation.
If you have a question about Stryker Hip Replacement Recalls and have a connection to Texas, please contact Robert Greening for your free consultation.