FDA Investigation Reveals Defects In Stryker's Hip Replacement Parts
*****The information in this article refers to the FDA's investigation that led to the 2008 Stryker hip implant recall. In July, 2012, Stryker has issued a second recall of its hip implants - this time for the newer Rejuvenate and ABG II models. For more information about the 2012 Stryker hip implant recall, click here for a new article. If you or a loved one has been injured by Stryker hip implants from either the 2008 recall or the 2012 recall, consult an experienced attorney for your legal options.*****
An investigation by the U.S. Food & Drug Administration (FDA) revealed that Michigan-based Stryker hip replacement parts were defective. The Administration sent warnings to the medical device maker outlining those defects and the consumer complaints it received.
Defects & complaints
After a six week inspection of Stryker's manufacturing plants, the FDA announced that some of the medical device maker's Trident hip replacement parts were defective and needed to be addressed. It also warned the company that it had received numerous consumer complaints about those devices. According to the warning letter, consumers complained to the FDA about the following issues with the company's Trident Hemispherical and Trident PSL Systems between January 2005 and June 2007:
- Product failure. Patients complained that some of the components failed due to poor fixation which led to fractures and fragments breaking off – causing them to undergo additional surgeries to correct the problems.
- Squeaking. Patients complained about excessive squeaking – again, causing some to undergo additional surgeries. Click here to hear a sample of one implant recipient's Stryker squeaky hip.
- Bone fractures. Patients complained about experiencing bone fractures due to improper seating of their Stryker hip implants in broached bones.
Even though the FDA's warning letter instructed the company to take “prompt action to correct the violations,” Stryker Defective Implant lawyers say the company has done little to correct these issues which has left many patients frustrated and angry and has prompted numerous Stryker hip lawsuits.
Stryker hip replacement lawsuits
Injured patients have filed hundreds of lawsuits against Stryker and New Jersey-based Howmedica Osteonics Corporation, the company who developed the Trident Hemispherical and Trident PSL cups and then marketed and sold the products under the Stryker name. The lawsuits allege that patients' Stryker hip problems were due to the company's defective products and that they failed to warn consumers about those defects.