If you are having pains or difficulty after the Calaxo screw in your ACl surgery, protect yourself and take action by contacting us. Learn about the recall and the questions to ask your doctor right away!
The United Kingdom has issued the immediate recall of all CALAXO Osteoconducive Interference Screws, used in Anterior Cruciate Ligament (ACL) reconstructive surgery. The UK CALAXO screw recall, issued in August 2007, affects all lot numbers and all item codes for product distributed since 2006, when the medical device was approved for use. CALAXO, manufactured by the Endoscopy division of Smith & Nephew, has also been used in ACL reconstruction surgeries in the United States since its US approval in 2006.
CONTACT US TODAY TO LEARN MORE ABOUT THE CALAXO SCREW RECALL
The UK CALAXO recall was issued because of rare, but potentially serious, CALAXO side effects. Worldwide, a small percentage of patients who have had CALAXO screws implanted during ACL reconstructive surgery have experienced pre-tibial soft tissue swelling. This CALAXO injury, which produces symptoms similar to infection, often develops anywhere from 2 to 36 weeks following surgery.
Of those patients who suffer CALAXO injuries, many require surgical intervention involving local debridement, or the removal of damaged tissues surrounding the implantation site, and removal of remaining screw fragments. Some require surgical replacement of the screw or bone graft.
Though the United States has not issued a CALAXO recall, the risks of CALAXO injuries are possible for patients in the US implanted with this medical device during ACL reconstructive surgery. It is unclear at this point whether such a recall of CALAXO screws will take place in the United States.
If you have received a CALAXO screw implant during ACL reconstructive surgery and have suffered from CALAXO injuries, you may have the legal right to seek compensation for your medical expenses and other losses. To learn more about your legal rights and options, contact the attorneys at Aitken * Aitken * Cohn today as there are time limits. Our experienced attorneys can evaluate your case to determine the best way to help you seek compensation for your losses and suffering.
What is the CALAXO screw?
The CALAXO Osteoconducive Interference Screw is a medical device developed by Smith & Nephew. CALAXO screws are used in ACL reconstructive surgery to secure the ligament graft. Unlike other screws used to anchor the graft during ACL surgery, which remain in the body permanently, the CALAXO screw is designed to be absorbed by the body over the 12-month period following surgery.
Additionally, the compounds in the CALAXO screw stimulate the body’s natural process of bone formation to encourage new bone growth in the tunnel where graft was placed. The medical device also promoted the ossification, or bone regeneration, of the graft.
What is the ACL?
The Anterior Cruciate Ligament, known commonly by its acronym, ACL, runs from the shin bone, or tibia, of the lower leg, through the center of the knee joint, and up to the thigh bone, or femur. The ACL is responsible for stabilizing the knee and preventing hyperextension and excessive rotation of the knee joint. The ligament also controls front and back movement.
The ACL can be torn during sudden dislocation, hyperextension (straightening of the joint past its normal position) or twisting of the knee. ACL injuries are common in athletes—such as football, soccer, basketball, and hockey players, skiers, and ice skaters—who make quick and/or frequent jumps or sustain blows to the knee.
What is ACL reconstructive surgery?
When an individual sustains an ACL tear or similar ACL injury, reconstructive surgery is often required to replace the ligament and return normal movement and functioning to the knee joint area. While several surgical methods are used to replace the ACL during reconstructive surgery, surgeons often use ligaments harvested from another area of the patient’s body.
To secure the graft in ACL surgery, screws are often used. While many screws used to secure the graft in ACL surgery are permanent, the CALAXO screw is designed to be reabsorbed by the body. Unfortunately, this screw poses the risk of causing local complications, which can require additional corrective surgery to alleviate the CALAXO injury.
What injuries can CALAXO screws cause?
The most common injury caused by CALAXO screws is local soft tissue swelling in the tibial area when the graft is often placed during ACL surgery. This CALAXO screw injury commonly develops between 2 and 36 weeks following ACL reconstructive surgery. The symptoms of CALAXO injury are similar to symptoms of post-surgical infection and may include:
· Fever
· Redness around the incision site
· Swelling near the incision area
· Constant or increased pain at the surgery site
If you experience any of these CALAXO injury symptoms, you may wish to consult with your medical care provider to determine the best method of care.
What treatment is required for CALAXO injuries?
Patients who suffer from CALAXO side effects may require additional surgery to treat these injuries. Some patients require the removal of damaged tissues from the affected area and removal of remaining screw parts from the original graft site. Other patients may also require surgery to receive an alternative screw or bone graft.
What if I have been injured by CALAXO?
If you have suffered an adverse reaction from CALAXO screws, you are also encouraged to report this event to the Food and Drug Administration, which is the federal government agency responsible for regulating medical devices and ensuring that products on the market are safe and effective. It is important to report problems with CALAXO screws so that the agency can take appropriate action to assure that the product is safe enough for unregulated use.
The FDA’s Medwatch Program—MedWatch: The FDA Safety Information and Adverse Event Reporting Program—allows consumers and medical care providers to voluntarily report any possible adverse events associated with medical products.
If you or a loved one has experienced complications following the implantation of CALAXO screws during ACL surgery, you may have the legal option to seek compensation for the cost of additional medical care, loss of income resulting from increased recovery time, pain and suffering you have endured because of CALAXO injury, and more.
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