On July 4th, Stryker Corp. voluntarily recalled its Rejuvenate Modular and ABG II hip implants. (The Rejuvenate Modular and ABG II Hip implants were approved by the FDA in 2008 and have since been implanted in over tens of thousands of patients throughout the United States.
These hip implants are known as metal on metal hip implants. A metal on metal hip implant is one in which both the ball, and the cup in which it articulates are made of metal. The Rejuvenate implant is made of a blend of Titanium, Molybdenum, Iron and Zirconium. It has a multi piece, or “modular” design. There is mounting evidence that these designs are problematic, as metal wear, known as fretting, can occur at each connection point in the modular design. Heavy metal wear debris has been linked to numerous health complications, including device failure and the need for revision surgery.
Since 2005, the FDA has received dozens of adverse event reports for the Rejuvenate and ABG III hip implants. The FDA approved Stryker’s metal-on-metal hip implant products finding they were substantially similar to other metal on metal devices in the market. However, there are severe and permanent risks associated with these devices. Documented complaints include:
- Metal Poisoning
- Adverse Local Tissue Reactions
- ALVAL (aseptic lymphocyte dominated vasculitis associated lesion)
- Squeaky Joints
- Pain and Discomfort around the area of surgery
- Parts breaking and wearing off in the body
- Bone Fractures
- Muscle Damage
Irrespective of the FDA’s prior recognition that metal on metal hip implants can be dangerous, metal on metal hip implants are still used in the United States. Patients are collateral damage of the FDA’s lack of oversight.