Stryker Corporation sets itself out as “the worldwide market leader in Total Hip Replacement products.” On July 06, 2012, Stryker Corporation voluntarily recalled its Rejuvenate Modular and ABG II modular-neck hip stems. These stems were associated with a risk of fretting and/or corrosion at or about the modular-neck junction which can lead to adverse local tissue reactions, including but not limited to inflammation and pain. Stryker recommends that patients who received a Rejuvenate Modular or ABG II modular-neck stem contact their surgeon.
On November 28, 2007, the Food and Drug Administration issued a warning letter to Steven MacMillan, then President and CEO of Stryker Orthopedics Corp. This letter was quite detailed, and the following paragraph is sample of its contents: “These violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, and verifying or validating the corrective and preventive action to ensure that such action is effective as required by 21 CFR § 820.1 00(a)(3) & (a)(4). Specifically, your firm received continual complaints from January of 2005 through May of 2007 concerning your Trident Hemispherical and Trident PSL cups that have failed to function and concerning hip implant components that have poor fixation. In some instances, these problems have required revision surgeries. In addition, complaints were also received between January of 2005 through April of 2007 for squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments). Furthermore, complaints were received between January of 2005 through June of 2007 concerning improper seating of hip implants in broached bones resulting in bone fractures. Your firm has failed to implement adequate corrective and preventive actions (which would include verifying or validating the corrective and preventive action to ensure that such action is effective) in order to prevent the recurrence of nonconforming product and other quality problems.”
If you live in California and have received a Stryker artificial hip and are experiencing problems such as loosening, popping, squeaking, unexpected joint pain, fracture, or need for additional surgery you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from Stryker Corporation. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.