Allegedly, several reports of Artelon spacer problems have been sent to the FDA from patients implanted with the CMC device. The agency has received reports of Artelon spacer problems in which the patient's body reacted to or rejected the implant; this reaction was marked by persistent pain, inflammation, and limited hand mobility.
According to reports, Artelon spacer problems have also led to bone loss and deterioration, requiring revision surgery to remove the device.
Issues & Symptoms
The Artelon CMC spacer was developed to treat early and mid-stage osteoarthritis which develops in the carpometacarpal thumb joint. According to the manufacturer, patients implanted with the thumb joint can expect joint stability, a quick recovery and minimal pain.
Unfortunately, the FDA has received numerous reports of Artelon spacer issues, and recent medical studies have revealed that the Artelon CMC Spacer is failing at a high rate.
Symptoms which may indicate Artelon spacer issues, including failure of the thumb joint, may include:
- Shooting pain
- Burning pain
- Inflammation and swelling
- Misshapen thumb
- Limited range of motion
In many instances, patients suffering from Artelon spacer problems needed painful revision surgeries to have the implant removed. Additionally, some patients have reported that the Artelon CMC Spacer can break apart while in the hand, requiring immediate second surgery.
In these instances, corrective surgeries will require the doctor to extract tendons from other parts of the body to repair the thumb joint.