August 13, 2012 — Last month, the Stryker Rejuvenate and ABG II hip implants were recalled due to increased risk of fretting and corrosion, which could cause severe complications that require revision surgery. There are already several Stryker Rejuvenate lawsuits that have been filed in New Jersey. As the litigation grows, there is also growing concern about another hip implant with a similar design — the Wright ProFemur. Although the Wright ProFemur has the same modular-neck design as the Stryker Rejuvenate and ABG II, the ProFemur has not been recalled.
Wright Medical Group was recently subpoenaed by the U.S. Attorney’s office in Tennessee. The company will be required to produce all documents and records related to the Wright ProFemur from January 2000 until August 2011. Hopefully, after the attorneys review these documents, the public will have a better idea how these hip implants remained on the market for more than a decade despite the fact that they have been linked to serious injuries.
The Stryker Rejuvenate, ABG II, and the Wright ProFemur all have a similar modular-neck design. In fact, Stryker based their approval application on the Wright ProFemur. Under the FDA’s 510(k) system, manufacturers of new devices can avoid conducting safety tests so long as they claim their device is “substantially equivalent” to an existing device.
A modular-neck hip implant is a unique hip implant design that allows a surgeon to interchange the femoral neck. The surgeon can choose among femoral necks of different lengths, angles, and sizes. This is intended to help the surgeon fit the hip implant to match a patient’s unique anatomy. It is different from most other hip implants, which have a solid piece for the femoral neck.
Unfortunately, the problem is that the metal-on-metal part of the neck may be prone to fretting and/or corrosion. Corrosion can cause tiny particles of metal to seep into nearby tissues, causing inflammation, pain, tissue damage, and other complications that require corrective revision surgery.
The modular-neck design was approved with little or no safety testing on people. Modular-neck hip implants may have seemed like a good idea, but without adequate safety testing, unanticipated defects can harm many people who assume their hip implant is safe.
If you were injured by a Stryker ABG II, Rejuvenate, or a Wright ProFemur hip implant, you may have a hip implant lawsuit and be entitled to compensation for your pain, suffering, medical expenses, and more.
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