Stryker has issued a voluntary recall of its Rejuvenate Modular Hip System and its ABG II Modular-Neck Hip Stem. The company has recalled these products because corrosion and wear can damage surrounding tissue. Patients may experience pain and/or swelling around the hip. Some may need a revision surgery to remove the defective device.
The Rejuvenate Modular Hip System was approved by the FDA in June 2008 as an extension to Stryker’s Modular Hip System product line. The ABG II Modular Hip Stem was approved by the FDA in November 2009. The ABG II system was approved because it was substantially similar to other Stryker Modular Hip Systems.
Patients have complained to the FDA about pain in the hip, difficulty climbing stairs and difficulty with hip flexion.
In May 2012, Health Canada announced a recall of Rejuvenate modular necks after Stryker reported that some patients required revision possibly caused by fretting/wear near the modular neck junction. Health Canada is the Canadian federal department responsible for helping Canadians track health issues.
Stryker says it needs to work with the medical community to better understand this issue. Stryker is attempting to collect data from patients who have received this hip. The company has established a call center for this purpose. The law does not require you to provide any information to Stryker. Contact The Gomez Law Firm today to protect your legal rights.