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Identifying Your Stryker Device

When Stryker Orthopaedics recalled it's Rejuvenate and ABG II hip implant models, thousands of hip replacement patients were left wondering if they were victims to these faulty devices. Most patients who undergo device implant surgery don't know the make and model of their implanted devices; they depend on the medical manufacturer and their physicians for the best product available. The Stryker recall in 2012 left patients struggling for answers.

Determining the identifying information about your recalled Stryker device is vital to your overall health. The complications from the Rejuvenate Modular and ABG II Modular-Neck stem models include metal corrosion and fretting, which is the leeching of metal shavings into the patient's bloodstream, tissue and bones. The metal components on the devices rubbed together, despite guarantees from the company that the Rejuvenate and ABG II were better than other brands. Because of these painful and sometimes deadly side effects, Stryker is now facing hundreds of lawsuits filed by injured patients and their families.

Tips To Identifying Your Stryker Device

Determining which kind of hip implant you have should be a relatively easy process. The federal Health Insurance Portability and Accountability Act (HIPAA) ensures that patients have open access to their medical records on request. With this in mind, there are several ways to get the information:

  • Contact the surgeon who performed your hip-replacement procedure or the medical records department in the hospital where the procedure was completed.
  • Ask to speak with the records administrator and request the name of your implant manufacturer, product name, lot number, model number and serial number.
  • Only the patients or the patient's legal representative is allowed copies of these records. All others must have written permission. Many providers will charge a copying fee.

It is important to get this information quickly after your hip replacement procedure because most providers are legally obligated to keep these records for only six years, depending on the applicable state laws.

Stryker's Rejuvenate and ABG II Model Differences

Both the Rejuvenate and the ABG II, released in 2008 and 2009 respectively, are made from Stryker's exclusive chromium and cobalt metal blend and covered in some areas with titanium. Both systems have interchangeable necks and stems to give patients more flexibility and stability and decrease the chance of hip dislocation. The models were made for different types of patients:

  • Stryker Rejuvenate: With six stems and 16 necks, this was marketed to younger patients who needed longer-lasting devices with a greater range of motion.
  • Stryker ABG II : This system has eight right stems, eight left stems and 10 necks and is designed for the older, less active patient.

Stryker Rejuvenate and ABG II Complications

The U.S. Food and Drug Administration (FDA) approved both Stryker devices through the federal agency's 510(k) clearance process. Through this, devices that are substantially similar to those already on the market do not have to undergo any clinical tests or premarket studies. Instead, the manufacturers are only required to collect data after the devices have been implanted.

In the case of the Rejuvenate and ABG II models, both were originally touted to resist fretting and corrosion. Instead, post-market data showed that a growing number of patients were suffering from a variety of side effects:

  • Metallosis – Caused by metal fretting, metallosis causes severe inflammation and an immune response.
  • Osteolysis and Necrosis – This type of bone and tissue death is caused by excessive metal debris collecting in the joint space.
  • Metal sensitivity – Some patients can have an allergic reaction to the metal components. The devices also cause pain, hip dislocation and possible neurological and heart damage from the increased metal ions in the bloodstream.