Howmedica Osteonics Corporation, DBA Stryker Orthopaedics, is a worldwide leader in Hip Replacement devices. The Stryker Corporation of Kalamazoo, Michigan received a six-page FDA warning letter detailing the problems with device and its manufacturing process. The letter also includes complaints that the Trident PSL and Trident Hemispherical Cups had poor fixation and they failed to function properly. There were multiple problematic reports received from patients who had Stryker’s hip implants.
The problems reported were:
- Difficulty in walking
- Severe pain
- Joints Swelling
- Squeaky joints
- Poor Fixation
- Fractured implants
- Improper fitting
- Bone fractures
- Revision Surgery
- Presence of Staphylococcus bacteria at the New Jersey facility.
Stryker issued a volutary recall of Stryker Rejuvenate and ABG II modular-neck stems in 2012. In the recall the company said it had “potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.”
COMPLICATIONS IN STRYKER IMPLANT
People who had the implants have experienced complications due to the wear and tear and corrosion at the junction of the neck and stem components. The Stryker stems are coated with titanium and necks made of cobalt and chromium. These metals rub against each another as the joint moves with regular activity. Due to constant friction between metal parts and between metal and bone, metal debris was found in the surrounding tissues and blood stream. This could lead to destruction of healthy tissues, inflammation, and metallosis and the need for a revision surgery.
Some people may notice lumps, or pseudo-tumors, form under their skin. These fluid-filled sacs are the body’s attempt to isolate the poisonous metal. Often, these pseudo-tumors do not appear on the skin’s surface and can only be identified using an MRI.
Even after the implants are removed, it takes time for the body to get rid of chromium and cobalt deposits from the system. In some cases presense of these metals could be detected even after a year of implant removal.
According to the Alaska Department of Epidemiology, cobalt levels of 5 are considered toxic. The signs and symptoms of cobalt poisoning can include visual, cognitive and auditory impairment, cardiomyopathy, hypothyroidism, peripheral neuropathy, rashes, blindness, deafness, and heart failure.