The Michigan based Stryker Corporation, a medical technology firm, has been the under the spotlight due to their medical device recalls. In 2012, Stryker was forced to recall the popular surgical implant or replacement medical products Rejuvenate and ABG II Modular-Neck Hip Stems due to their connection to patient problems and negative side effects.
Rejuvenate and ABG II Modular-Neck Hip Stems were unlike any of the current hip implant technology on the market. At that time the market was known for using a one-piece neck and stem construction, but the Rejuvenate and ABG II Modular-Neck Hip Stems were constructed using a system of multiple stem and neck mechanisms. The multiple components were instrumental in allowing for a more custom fit for implant or replacement patients. The products’ qualities including the system of multiple components, coupled with theoretical stability, longevity and larger range of motion, allowed Stryker Corp. to advertise the Rejuvenate and ABG II Modular-Neck Hip Stems as one of the top of the line performance surgical products, especially to younger patients in need of implant procedures.
Stryker also made their Rejuvenate and ABG II Modular-Neck Hip Stems with an alloy that allegedly was stronger than other alloys being used on that time’s current market. Stryker additionally claimed that their alloy blend “resembles that of bone.” The alloy blend consisted of titanium, iron, molybdenum and zirconium. Stryker maintained that this blend would deter metal corrosion and fretting, which is where small metal flakes break off and enter into the body. Unfortunately, Stryker was incorrect and the alloy blend based products caused serious negative side effects, predominantly the release of combinations of toxic metals into the body of the implant or replacement patient.
In April of 2012, an “Urgent Filed Safety Notice” was issued to surgeons and hospitals for the Rejuvenate and ABG II Modular-Neck Hip Stems claiming “excessive metal debris and/or ion generation” being caused by the “fretting and/or corrosion at or about the modular neck junction.” Those patients negatively affected are in the need of replacement and correction procedures which have shown to be costly.
Patients claiming negative outcomes related to the Stryker product having been negatively affected by, but not limited to:
- Implant failure
- Severe joint pain
- Deterioration of bone around the implant are
In 2013, Stryker spent in excess of $510 million in costs related to recalls. The number of current lawsuits against the company is steadily growing. Stryker estimated, in regulatory filings submitted by the company at the end of 2015, that the recall and the litigation process is going to reach as large as $1.13 billion.
If you or a family member have had a Stryker Rejuvenate or ABG II Modular-Neck Hip Stems procedures and/or are experiencing negative outcomes or side effects due Rejuvenate and ABG II Modular-Neck Hip Stems, please contact us at 616-227-8444 or via our web page at www.naumeslaw.com.