Conventional Hip Implants vs. the Stryker Rejuvenate and ABGII

While more traditional hip implants are made up of only two pieces, Wright Medical was the first to introduce a stem and neck split into two separate pieces rather than one. Stryker Orthopedics soon followed suit with two pieces inserted into one another then the ball portion of the Stryker implant is placed on the end of the neck. While the Stryker hip implant models are not considered true metal-on-metal implants, where the metal stem inserts into the metal neck, there exists a metal-on-metal junction. Once the device is implanted into a patient, this junction receives a tremendous amount of stress and can be subject to friction between the metal parts.  

Less Susceptibility to Hip Fracture a Tradeoff for Tissue Necrosis?

Friction can lead to corrosion at the location where the modular metal neck snaps into the body of the femoral stem. While this particular design may have lessened the patient’s susceptibility to hip fracture, the resulting metal debris can cause tissue necrosis and the formation of pseudotumors.  Both the Rejuvenate and the ABGII offer a variety of stems and necks to allow the surgeon to more fully adjust the hip implant to the individual patient’s body type. The Rejuvenate in particular was oriented to a younger populous as a longer-lasting device which would offer the patient a superior range of motion. Both the Stryker Rejuvenate and the ABGII were touted as offering increased stability as well as more elasticity during the implant procedure.

Both DePuy and Stryker Hip Implant Models May Result in Metal Toxicity

Unfortunately, only a short time after these devices received FDA approval, adverse patient reports began coming in. Once the Rejuvenate and the ABGII were implanted into patients, there were instances where the stem and neck rubbed together causing microscopic metal ions to shear away from the implant into the surrounding tissue or the bloodstream of their recipients.  When those metal shards became lodged into the surrounding hip tissue, destruction or death of the tissue often occurred. Metal toxicity from the metal ions entering the bloodstream were also found to cause significant health problems including cardiovascular, kidney, thyroid and even DNA alterations. Revision surgery became the only option for many of those implanted with a Rejuvenate or ABGII. Unfortunately, this particular revision surgery comes with serious risks since the neck of the device is implanted deeply into the femur. When the implant is removed the patient may be left with very limited mobility due to tissue and bone damage.  

The Process of FDA Approval

The Rejuvenate was granted approval by the FDA in June of 2008 with the ABGII following quickly on its heels, receiving FDA approval in November of 2009. Both of these hip implant devices received approval under the 510(k) process which has been criticized by many as being much too lenient for medical devices and drugs. The 510(k) approval process allows drugs and medical devices to gain FDA approval without the necessity of clinical trials. The drug or device in question must simply be shown to be more or less the same as a device or drug already approved. Demonstration of product safety is not necessarily a requirement of approval under this particular process which means that flaws generally only surface after the devices have been implanted into recipients. Perhaps even worse, the Stryker hip implant appears to have been patterned after a hip implant device which had already demonstrated some adverse health risks. Stryker markets over 57,000 products across the world which generate over $8 billion dollars in revenues for the company.

Differences and Similarities between DePuy and Stryker Implants

The DePuy metal-on-metal hip implant has come under fire due to the metal components which rub against one another during periods of physical activity, causing tiny metal ions to shear off. These ions may lodge into the surrounding tissues or could potentially enter the patient’s bloodstream, either of which can be extremely dangerous. Initially it was believed that because Stryker’s design does not incorporate a metal ball rubbing against a metal socket, it would not be subject to the same types of metal toxicity in its recipients. As it turns out, the neck of the Stryker hip implants are made of cobalt and chromium, the stem is titanium-coated and there is a metal-on-metal junction involved which gives recipients of the Stryker Rejuvenate and Stryker ABGII the risks of metal toxicity.

The Recall

Three months prior to the voluntary recall by Stryker of the Rejuvenate and ABGII, the company issued a safety alert to surgeons and hospital risk management personnel regarding these particular implants. They stated potential hazards of excessive metal debris caused by corrosion and fretting at the modular neck junction. When the actual recall was issued in July, 2012, it is estimated over sixty adverse reports had been received claiming metal toxicity. Those patients could likely be subjected to revision surgery which is very complex and risky due to the fact that the Stryker hip implant goes deeply into the femur. Positive outcomes in these revision surgeries may not be the norm with many Stryker hip implant recipients being left with a diminished range of motion.

If You Are a Stryker Hip Implant Recipient You Must Seek Medical and Legal Advice

Of course the first order of business if you’ve been implanted with a recalled Stryker Rejuvenate or Stryker ABGII is to seek medical advice. See your physician and discuss your implant as well as any health problems you’ve had as a result of the implant. Even if you have not yet suffered adverse health effects from the hip implant, you should still see your doctor. In the same vein, you should also seek qualified legal advice so you will have all the information you need should you decide to file a claim against Stryker within the statute of limitations for your particular state.

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