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Calaxo screw Soft Tissue swelling is a serious side effect for which medical intervention is often necessary. The Calaxo screw, voluntarily recalled by its manufacturer in 2007, is used in surgery for the reconstruction of a torn or damaged ACL (anterior cruciate ligament) in the knee. When the use of a Calaxo screw causes soft tissue swelling, a patient may have to have repeat surgery for removal of the screw(s).
The Calaxo screw was approved for use in the U.S. by the FDA in early 2006, and reports of serious Calaxo side effects began to arise not long thereafter. By October 2007, the company that makes the Calaxo screw (Smith & Nephew) was aware of cases of Calaxo screw soft tissue swelling in the U.S. and the U.K. About 200,000 people suffer a torn ACL injury each year in the U.S., and about half of these individuals undergo reconstructive ACL knee surgery.
When the Calaxo screw was recalled in the U.K., the UK-version of the FDA estimated that 0.3 percent of patients with Calaxo screws worldwide developed pretibial soft tissue swelling. In the U.S., this percentage would translate into 300 patients developing Calaxo screw soft tissue swelling each year.
The Calaxo screw related Soft Tissue swelling is usually "pretibial" — that is, above the shinbone. The swelling appears anytime from a few days to six months after the surgery during which the Calaxo screw was implanted. The complete list of Calaxo screw soft tissue swelling symptoms is:
These symptoms mimic those of a Calaxo screw infection, and Smith & Nephew have recommended that surgeons treating Calaxo screw complications aspirate the area affected by soft tissue swelling, to take a culture for examination. The cause of the soft tissue swelling has not been identified, but fragmentation (breaking of the screw into pieces) is one possible cause.
If you had ACL reconstruction in the U.S. in 2006 or 2007, Calaxo screws may have been used in your surgery. If you have suffered Calaxo screw soft tissue swelling contact us today to schedule a private consultation with a Calaxo lawyer who will help you recover compensation for your losses.
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