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Calaxo Bone Screw Causing Painful Complications for ACL Surgery Patients

Mar 18, 2009 | Parker Waichman LLP

A simple medical device called the Calaxo Bone Screw has been causing a great deal of pain and suffering for those who have undergone Anterior Cruciate Ligament (ACL) reconstructive surgery.  The Calaxo Bone Screw was recalled in August 2007 due to reports of serious complications.  Some patients even had to have repeat surgeries to have the Calaxo Bone screw replaced.

The ACL, which runs from the tibia, or shin bone, through the knee joint and to the femur or thigh bone, helps stabilize the knee and control front-to-back movement. ACL tears are most frequent among athletes who participate in sports such as soccer or skiing that require them to jump or change direction quickly and frequently.

In most cases, an ACL is repaired by  using  a ligament harvested from another part of the patient's body as a graft. This graft rests within the knee joint, anchored in tunnels that have been drilled in the thigh and shin bones. A screw would typically be used at the tibial end of the graft.  Historically, these screws have been made of metal.

The Calaxo Bone Screw, manufactured by Smith & Nephew, was approved by the Food & Drug Administration (FDA) in 2006.  Unlike other screws, the Calaxo Bone Screw is made of PLC, a blend of bioabsorbable polymer and calcium carbonate.   Ideally, the Calaxo screw will be  reabsorbed by the body in the 12 months following surgery, and the compounds within the screw will stimulate new bone growth  in its place.

Unfortunately, the Calaxo Bone Screw does not always work as intended.  The device was recalled in both the U.S. and the United Kingdom in August 2007 because of reports of patient reactions.  The most common injury caused by Calaxo screws is local soft tissue swelling in the tibial area. Symptoms of such an injury include:

  • Fever
  • Redness around the incision site
  • Swelling near the incision area
  • Constant or increased pain at the surgery site

This Calaxo screw injury  generally occurs between 2 and 36 weeks following ACL reconstructive surgery.  These injuries are serious and sometimes  require additional surgeries to remove both the damaged tissues from the affected area, and  remaining screw parts from the original graft site.  Some patients may also require surgery to receive an alternative screw or bone graft.

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