Stryker Orthopaedics have recalled the Rejuvenate Modular and ABG II modular-neck hip replacements due to the risk of failure, squeaking, and corrosion at the neck junction. Metal debris from corrosion can cause chronic pain, swelling, metallosis, and hip implant failure. Patients suffering from Stryker hip implant failure may require revision surgery, which can be extremely painful, expensive, and debilitating.
Do I Have a Stryker Hip Implant Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Problems With Stryker Rejuvenate and ABG II
Stryker Orthopedics has sold the Rejuvenate Modular Primary Hip System and the ABG II Modular-Neck Hip Stems since 2010. When the devices were approved, the manufacturer claimed that the design could reduce failure rates. Instead, the products were recalled because severe corrosion around the neck joint could cause metal debris to accumulate. Over time, this could cause a local tissue reaction, leading to tissue death. Patients with this complication could suffer from severe pain, inflammation, and swelling, and they could need revision surgery.
Stryker Hip Implant Recalls
Stryker Orthopedics has recalled the following hip implants:
Stryker Hip Implant Recall in Canada
On April 30, 2012, Stryker announced a recall of several Rejuvenate Modular hip implants in Canada. The following devices were recalled:
- Rejuvenate Modular Neck, 0 DEG
- Rejuvenate Modular Neck, 8 DEG
- Rejuvenate Modular Neck, 16 DEG
- Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ
In the official recall notice, Stryker said that the recall was due to a fretting and/or corrosion around the device’s neck joint, which led to a failure rate of “less than one percent.” This corrosion issue is the same one that prompted the U.S. recall two months later.
Stryker Warns Surgeons of Hip Implant Risks
Stryker sent an Urgent Field Safety Notice to orthopedic surgeons in May 2012, warning that corrosion and metal poisoning associated with the ABG II Modular Stems and Rejuvenate Modular Necks could lead to device failure.
The letter contained warnings about the following risks associated with the hip implants:
- Squeaking or abnormal sounds in the hip (popping, clicking, grinding, etc.)
- Excessive metal ions, metal debris generated by fretting and/or corrosion. This debris could accumulate in the joint spaces
- Pain, Inflammation, Metallosis (metal poisoning), tissue damage/death due to excessive metal debris in contact with tissue
- Allergic reaction to metal debris, especially in patients with pre-existing metal sensitivity
- Bone loss due to metal debris
Stryker Hips Fast-Tracked through FDA Approval
The Stryker Rejuvenate Modular and ABG II modular-neck hip replacements were fast-tracked through the FDA’s approval process under the 510(k) clearance program. Under this program, new devices that are “substantially similar” to another FDA-approved device do not need to conduct safety studies. This means that Stryker’s recalled hip implants did not go through clinical trials before they were marketed, sold, and implanted. Unfortunately, just because a device is “similar” to an existing device does not mean that it is safe.
Symptoms of Hip Implant Failure
- Swelling, inflammation
- Changes in gait or walking ability
- Dislocation and/or loosening of the hip joint
- Metal poisoning
- Bone loss
- Tissue damage
Do I have a Stryker Hip Implant Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Stryker hip implant lawsuit review.