Stryker Rejuvenate and ABG II Hip Implant Recall: FDA Warning

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Stryker Howmedica Corporation is one of the leading manufacturers of hip implant products, and for a period of more than three years, the company has been receiving complaints in regards to its implants.  As is almost always the case, these complaints began with those who used the products, and ultimately the FDA got involved with the situation as these complaints continued to be generated.

Stryker Rejuvenate and ABG II Hip Implant Problems and Recall:

Below is a brief overview of the FDA’s involvement with Stryker and its Rejuvenate and ABG II hip implant products, including the most recent news that was released in an announcement on July 6, 2012.  The persistent health problems associated with faulty metal-on-metal hip implant systems continue with the announcement that Stryker's Rejuvenate and ABGII Modular-Neck Hip Implant stems are subject to corrosion and could pose serious risks of infections and other health issues for patients who are wearing the units. Among the possible health problems that have been identified are soreness, pain, hip implant failure, infections and the need for replacement systems, all of which are issues that have been identified with global recalls of other metal-on-metal systems that have alarming high rates of failures.

Meantime, if you have been injured or are at risk as a result of using these products, you need to seek immediate medical attention to diagnose any problems that already exist or that could arise, and you then need to contact a defective medical products attorney to schedule an initial consultation.

 

Stryker Consumer Complaints: Squeaky Joints

The first sign of trouble for these Stryker products surfaced in January of 2005, when reports of multiple complaints by consumers using the product began to hit the news.  These complaints consisted of several serious problems, including extreme pain in the surgical area, squeaky joints, the tendency for parts of the implant to break off and/or wear down unevenly, creating extreme pain and discomfort, and finally and perhaps most seriously, improper fittings of these implants that ultimately led to bone fractures in the patients’ bodies.

FDA Investigation of Stryker Hip Implants

The FDA became aware of the problems and began to investigate Stryker and its products in accordance with its customary procedures.  The FDA sent inquiries to Stryker, and one can easily deduct that the responses to these inquiries over time were inadequate, as it wasn’t long before the FDA took additional steps.

List of Problems with Stryker Hip Rejuvenate and ABG II Implants:


During the summer of 2007, the FDA spent six weeks inspecting Stryker’s manufacturing facility in Mahwah, New Jersey, and as a result compiled a list of problems.  Included among them were deficiencies in the quality control stages of manufacturing and the presence of disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria.

As a result, the FDA sent a stern warning to Stryker in November of 2007 warning them that if these problems were not corrected immediately, the FDA would begin to seize property, file injunctions and warn government agencies not to award contracts to Stryker based on the problems discovered.

Stryker Issues Recall Notice


Stryker announced that it was recalling two products within the company’s Trident line.  The Stryker Hip Implant component recall involves two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland.  Neither of these recalls is directly related to the issues discovered at the New Jersey plant, which could result in even more investigation into this problem.

Your Next Step if injured from a Stryker Rejuvenate and ABG II Hip Implant


If you or someone you love has been injured or suffered as a result of these products, contact a defective medical device attorney as soon as possible to schedule an initial consultation.

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Stryker Hip Rejuvenate and ABG II Implant FDA Warning and Recall Information page updated on 3/06/2013