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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April 13th, 2009 at 8:28 am
Was the Calaxo screw only used in ACL surgeries? My son broke his arm in 3 places in June of 2007 and had to have plates and screws put in. Part of his forearm is swollen and his arm has been hurting him. Would those screws have been used in his surgery?
April 22nd, 2009 at 5:03 am
Would this screw been used in total knee replacements? I have had to have 2 done on my left knee. I am disabled because of the operations. I wish I could have my leg cut off the pain is so bad!!
April 29th, 2009 at 1:58 pm
I had my acl done in febuary of 07 my knee is still very weak and I still have pain especially where scews are it is very tender still . I cannot run. I feel lumps where the screws are. How do I know if I have calexo scews in me ? I have been to the hospital twicw. For knee pain they just thought I was a junkee looking for meds. Please help
May 1st, 2009 at 4:09 am
I underwent a mid-foot fusion in Oct/08 where the bones in my foot had to be rebuilt. The bones where fused together with a bone graph from my tibia then metal plates and screws were used. I found out on March 31, 2009 that two of the screws in my foot are broken. I now need to undergo another surgery to have the broken screws removed and replaced.
What are my options?
May 27th, 2009 at 6:48 pm
Concerned about this news. How do I find out what type of screws were used in my ACL and meniscus surgery? I have had several problems with this knee since original surgery including the mentioned symptoms.
June 5th, 2009 at 3:51 pm
Is this still being used in 2009? Also wondered if this could have been used to repair bones broken in the foot? My mother in law had many complications after surgery due to screw(s) used in her foot backing out.
August 4th, 2009 at 5:52 am
I have had a ACL repair after beeing in servere pain on a daily basic i found a doctor that have let me know that i will need a knee replacement i have to walk with a cane.The complications that i am going through is a on going pain all of the mentioned symptons i do have .i have been told by a doctor that i need to see a head doctor he dont know why there is pain. He didn’t believe the pain even though there was a lot of swelling.could i have potential calaxo screws
October 6th, 2009 at 12:07 pm
I had ACL surgery in October of 2006. After my surgery my knee became infected and has been extremely week ever since. I played college football and could never get my strength back to what it was. About a month ago I noticed a bump on the inside of my knee just to the right of the incision. This past weekend it ask become more and more swollen and super sensitive to the touch. Talked to my trainer and doc and they said my screw is coming out. I wsa told they were to desolve 12 months after surgery.