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Stryker’s Rejuvenate and ABG II Hip Recall-Tip of the Iceberg?

Posted On November 19th, 2013 By CSSFIRM.COM

Over the last several years, we have had the benefit of meeting with orthopedic surgeons, mechanical engineers and patients alike in discussing the results of failed hip implants following a revision surgery. No one knows how high the ultimate revision rate will be, but with greater awareness and scrutiny, the ultimate failure rate will become known in the years to come.  But with many patients, there still has not been adequate monitoring and follow up care to inform them about these recalled hip devices.

It is essential that the client be told and educated as to the potential harms caused by the Stryker Rejuvenate and ABG II hip implant devices.   Many patients have not even been recommended for basic testing to check for elevated metal ion levels.  Some practices have not notified patients that they implanted defective and recalled hip devices.  We have seen this same pattern in other device litigation.  It is now recommended by the FDA that physicians now follow a patient that has a Metal-On-Metal device.   Though the recalled Rejuvenate and ABGII by Stryker is technically not a metal on metal device (defined by  the articulation of the ball and socket),  the metal ion release of chromium cobalt occurs much the same  in this device as it does in other  Metal-On-Metal devices.   Many physicians have unfortunately relied on patients to make follow up appointments and have not been pro – active in reaching out to their patients about the Stryker Recall.

At the time of implant an instruction is commonly given such as “come back in 1 year” or “come back if you have problems”.   Some physicians take the view that the responsibility to later be notified and/or tested is something to be discussed only at the follow up visit. Thus often no effort will be made to find and notify the patient of the recalled device before that follow up visit. Man patients unfortunately learn later that they had an inflammatory process that has been damaging their soft tissues and bones thereby needlessly may have exposed them to additional harms due to a prolonged inflammatory process.

The Rejuvenate stem bodies are made of TMZF alloy, a proprietary Stryker material with a plasma sprayed coating of titanium and PureFix HA. The modular necks are made of the hard Cobalt/ Chromium (CoCr) alloy. The failures observed do not appear to soley be the result of the usual corrosion/fretting process (battery effect)  but instead may appear to be the simple result of a hard  Cobalt/ Chromium (CoCr) element working against a soft TMZF (titanium, molybdenum, zirconium, iron)alloy in a pure fretting scenario.  The corrosion observed  has been described as  secondary, not primary.  Nonetheless, it is important that a patient be monitored and followed and we hope that physicians will follow the minimum recommendations adopted by the FDA in following these patients.

Richard Schlueter of Childers, Schlueter & Smith LLC represents harmed patients with faulty orthopedic devices.  He currently is appointed to the Plaintiff’s steering Committee ( PSC )[national leadership position] concerning the  Stryker Rejuvenate and ABG II hip replacement implants by Judge Donovan W.  Frank pending in MDL 13-2441 in the District Of Minnesota .  Childers, Schlueter & Smith, LLC continues to investigate and review the claims of patients nationwide who received a Stryker hip implant device. If you, or a loved one, has received the Stryker Rejuvenate and/or Stryker ABG II Modular-Neck Stem and have experienced some type of hip pain, elevated blood ion levels, developed metallosis, required an additional hip surgery, or any failure with your hip replacement device, you may want to contact CSS Firm for a free case evaluation and consultation or call the firm.  Other Orthopedic  devices that our firm handles include products manufactured by Stryker; DePuy Orthopedics; Wright Medical; Zimmer; and Biomet.

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