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U.S. Recall

Stryker Orthopaedics recalled its Rejuvenate Modular and ABG II modular-neck hip stems on July 4, 2012. (announced by FDA on July 6, 2012).

The Stryker Rejuvenate is not a metal-on-metal hip device, but it does have metal-on-metal components. Unlike most femoral components, which consist of one part, the modular femoral neck-stem involved in this recall features two metal parts that fit inside of each other.

The ABG II Modular Hip System was first marketed in November 2009 and the Rejuvenate Modular System came onto the market right after that in either late 2009 or very early 2010.
According to Stryker, modular hip replacements are designed provide surgeons with an ability to better fit an individual’s natural hip geometry in technically challenging situations, and they have been promoted as providing improved stability and range of motion, due to the custom fit. This has resulted in the modular hip replacements being used among many younger and more active patients

These were not considered metal on metal hips at all until recently, since they don’t use a metal on metal ball and cup like the ASR and Pinnacle MOMs and other standard MOMs. They were actually thought of as a very good alternative to MOMs for a while because of this.

Instead, there is a problem where the neck is pressed into the stem, and the junction of these two pieces takes most of the load over the life of the hip. The necks are made out of a chromium and cobalt alloy and they have two problems – corrosion and wearing of the neck from very slight movement in the stem if it loosens a little – which both can release ions.

The recall was initiated due to the potential risks associated with modular-neck stems, including the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.

Stryker released a report in early 2012 which stated that patients with these modular hips may exhibit the same metallosis issues plaguing metal-on-metal artificial hips. Stryker’s own clinical information report, which was released to highlight the benefits of modular neck stems, actually raised concerns about findings that individuals who received modular-neck femoral components may experience corrosion and wear of the component as the metal neck rubs against the metal stem.

According to the report, “In vivo production of metal debris from implants has been the subject of much scrutiny recently. Metal on metal bearings, for example, produce small (20-80mm diameter) metallic wear debris whenever motion is present … elevated blood serum metal ion levels (it is believed these metal ions are produced by corrosion of the wear debris in the case of metal on metal joints) and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articular surface bearings, causing premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation … It has been shown that a similar reaction and potentially premature failure of the total hip arthroplasty may occur in rare cases of patients with both modular head and modular-neck femoral components.”

In April 2012, Stryker Orthopedics issued an Urgent Field Safety Notice indicating that patients could potentially develop metallosis from the ABGII Modular Stems and ABGII Modular Necks, and the Rejuvenate Modular Stems and Rejuvenate Modular Necks, which could lead to complications like bone damage, immunological problems, significant pain, allergic reactions, tissue damage and death, and elevated blood levels of cobalt.

In a May 2012 article entitled Evaluation and Treatment of Painful Total Hip Arthroplasties With Modular Metal Taper Junctions, doctors are advised that surgical intervention is necessary once a patient is diagnosed with an adverse local tissue reaction to corrosion occurring at the neck/stem area. The article also highly recommends that the entire femoral stem be removed and replaced with a femoral component that is one piece and that does not use a modular neck/stem system.

Your Potential Claim

Based on this information and your state’s statute of limitations, it is best to protect your legal rights now if your hip system has failed or fails in the future. If you believe you have a Hip implant system using a Stryker Rejuvenate hip system, an ABG II modular-neck stem, or any other metal-on-metal hip implant system, it is important that you identify which hip systems you had implanted. You may qualify for compensation.

If you would like Levin Simes LLP to investigate your potential claim, please fill out the contact form on this page, call us at 1-888-426-4156 or email us at info@levinsimes.com. We look forward to discussing your case with you.