Tuesday, October 9, 2012

Cancellation of Stryker Hip Implant Systems




In 2008, a Stryker hip implant recall was conducted in the U.S by Stryker Orthopedics. Another recall was ordered in 2012. Stryker is an orthopedic device manufacturer who develops and distributes several artificial hip systems. Since the initial recall, Stryker is already facing many accusations from patients who were having issues with their Stryker hip replacements.

Patients with Trident, Rejuvenate, and ABG II hip systems surgery claim to experience painful discomforts, unstable movements, skeletal degradation, unfamiliar device sounds, implant dislocation, and device defects. In order to be compensated with the injury, several patients experiencing these adverse results have sued Stryker for their hip implant system.

The FDA gave an approval for Stryker Trident Implant in 2003. This version of hip system is an improved ceramic-on-ceramic design preceding the metal and plastic version. Bad feedbacks and complaints against the attachments of Trident hip replacement began to arrive in 2005.

These complaints initiated FDA to conduct an inspection on the Stryker facilities in Ireland and New Jersey in 2007. The two factories however failed the inspection. FDA evaluated that the company did not utilize the standard manufacturing guidelines in terms of production, storage, and packaging. In addition, Stryker received a poor mark on manufacturing their hip system products. Reports of several health complications and defective devices are also documented by FDA who later issued several warnings for Stryker. Consequently, the company voluntarily ordered a product recall on their Trident Acetabular and Hemispherical Cup System on January 22, 2008. Many Stryker hip implant lawsuits followed after the recall. All Stryker hip replacement lawsuit were later consolidated in Atlantic County in March 2009. Stryker was able to develop new hip replacement designs called as Rejuvenate Modular System and ABGII System. These new designs of hip devices were given an approval by FDA in June 2008. The two-part modular neck and stemming designs that promises a more flexible and stable mechanism. However, negative reviews and health risks were reported a few months after the launching of the new hip implant designs. Metallosis and further complications affecting the soft muscle tissues and bones were the usual complaints.

There are currently more than 60 records of Stryker Rejuvenate and ABGII hip implant issues received by the FDA. These reports were given by patients who had the Rejuvenate and ABGII implants. These later made Stryker Orthopedics released another recall order for all Rejuvenate and ABGII modular-neck systems last July 6, 2012.
  


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