Last summer, Stryker recalled its Rejuvenate and ABGII modular-neck hip stems, citing possible corrosion which could lead to "metallosis, necrosis, and/or pain" and the potential need for revision surgery. Last month, the self-proclaimed market leader in total hip replacement systems followed up on that recall with an urgent field safety notice.
That notice recommends that doctors:
- conduct an exam including blood work and cross-sectional imaging "regardless of whether a patient is experiencing pain and/or swelling"
- perform follow-up tests
- be on the lookout for aseptic loosening and periprosthetic sepsis
- perform revision surgery with another device if the patient is suffering adverse side effects from metal wear.
Likewise, Stryker's website suggests that the more than 20,000 patients implanted with these devices schedule an exam whether or not they are suffering pain.
Though not a true metal-on-metal hip implant like the recalled DePuy device, which has a metal-on-metal ball-and-socket design, the custom-fitted neck is made with chromium and cobalt before being coated with titanium. When the neck rubs against the stem, metal debris may be deposited in the patient's bloodstream.
"Any time there is a metal-on-metal articulation, tiny flecks of metal are shaved off and released into the area," states bonesmart.org. "It also produces tiny particles called metal ions which human tissue doesn't much care for … bone and soft tissue can be destroyed as the body tries to respond to the metal ions."
Thus, patients may suffer pain, inflammation, tissue death, or the formation of pseudotumors, or tumor-like masses.
Stryker has offered to reimburse patients for testing, treatment, and revision surgery, but many injured patients are filing lawsuits against the company, which applied for FDA approval of its recalled devices under the FDA's 510(k) — or "fast track" — program. By filing those applications, Stryker stated its devices were "substantially similar" to devices already on the market and did not have to conduct patient safety trials. Unfortunately, of one of those devices — the Wright Medical Profemur Total Hip Implant system — has been the subject of its own litigation due to a high failure rate.
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