Monday, October 8, 2012

Modular-Neck Hip Stems on the Stryker Rejuvenate and ABGII

The Stryker Orthopedics design for the Rejuvenate was considered quite innovative when it was introduced in 2009 after being FDA approved in June of 2008. Conventional hip implants have a one piece neck and stem while the Rejuvenate and ABGII hip implants are made up of several components. The ABGII hip implant system has sixteen left and right stems and ten modular necks. The Rejuvenate hip implant has fewer stems—only six—and sixteen necks and was presented to younger patients with limited hip mobility. Stryker thought the Rejuvenate was a longer-lasting device which offered superior freedom of movement. The idea behind the new design was to give surgeons more flexibility in fitting the hip implant to the individual patient as well as to allow for a more anatomically correct implant.

The heightened stability and intra-operative elasticity allowed surgeons to choose from a variety of neck and stem mixtures to more fully customize the hip device. A short time after the introduction of the Rejuvenate, some adverse patient reports began coming in. Once the hip device was implanted into the patient, the stem and neck sometimes rubbed together, shedding microscopic ions of metal debris into surrounding tissue. Once the metal shards lodge into the surrounding tissue there is the potential for serious damage to the muscle and tissue as well as bone damage and total implant failure requiring revision surgery.

History of the Rejuvenate and ABGII

The Stryker Corporation markets over 57,000 products worldwide, generating a staggering $8 billion in annual sales. The Rejuvenate received FDA approval in June, 2008 while the ABGII hip implant was approved in November of 2009. Both hip implants were submitted through the controversial 510(k) process of the Food and Drug Administration. This program allows medical devices and drugs to be implanted in recipients without benefit of clinical trials so long as it can be shown that the drug or device is essentially similar to a product which has already garnered FDA approval. Both Stryker devices were approved under this program. What this essentially means is that product safety was not required to be shown prior to implanting the devices in patients, meaning flaws are only discovered after implantation. To make matters worse, the Stryker devices appear to have been patterned after other hip implant systems which had already begun to exhibit problems which could potentially lead to bone fractures and negative tissue responses.

The Similarities and Differences to the Recalled DePuy Hip Implants

One of the primary complaints regarding the DePuy metal-on-metal hip implant is that during normal wear, the metal ball and socket rub against one another causing tiny metal shards to shear off, lodging in the surrounding tissue or entering the bloodstream. Because Stryker’s Rejuvenate and ABGII do not involve a metal ball rubbing against a metal socket they are not considered true metal-on-metal devices. The necks of the Stryker hip implants are made of cobalt and chromium, while the stems are coated with titanium; and there is a metal-on-metal junction which means the Stryker hip implants have some of the same risks of metal toxicity as the DePuy hip implants.

The Stryker Rejuvenate Recall and the Stryker ABGII Recall

In April of 2012, just three months before Stryker recalled the Rejuvenate and the ABGII, the company issued an urgent safety alert to surgeons and risk managers in hospitals regarding these two hip implants. According to the communication, the potential hazards were listed as “excessive metal debris and/or ion generation” caused by “fretting and/or corrosion at or about the modular neck junction.” By the time the Stryker Rejuvenate and ABGII were recalled the FDA had already received over 60 adverse reports regarding metal toxicity which required the recipients to undergo revision surgery. The stems of the implants have been found to have a high rate of Stryker hip corrosion and fretting, leading to total failure of the hip implant. Because the neck of the Stryker models goes deeply into the femur bone, revision surgery is considered very complex and may not have a positive outcome.

Getting Legal Help

For those who have been injured by the recalled Stryker Rejuvenate or ABGII, it is important they speak to a highly experienced, knowledgeable Stryker hip recall lawyer in order to receive a comprehensive evaluation of their individual case. Even if the Stryker hip implant has not yet failed or the patient has had no overt symptoms metal toxicity or inflammation, those with these two implants should nonetheless seek a legal opinion in order to avoid the possibility of going over the statute of limitations. Should this occur, the patient would be forever barred from recovery even if, later on, it was found that the Stryker hip implants were responsible for serious medical problems.

Author: Sullo & Sullo Attorneys

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