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On April 12, 2011, Pennsylvania Court of Common Pleas Judge Sandra Mazer Moss decided that all cases involving faulty Artelon Spacer implants should be treated as a mass tort. Complaints will be handled as one unified program and managed by Pennsylvania’s Complex Litigation Center.
The Artelon CMC Spacer
The Artelon CMC Spacer was developed by Artimplant AB and marketed by Small Bone Innovations, Inc. In 2007, the Food and Drug Administration approved the device for use in the United States.
The device was intended to treat early and mid-stage osteoarthritis that occurs in the carpometacarpal thumb joint. Osteoarthritis causes the cartilage to breakdown until the thumb joint can no longer provide cushioning for the bones. The Artelon CMC Spacer is supposed to provide a substitute cushion.
The implant only requires outpatient surgery. Doctors place a T-shaped plastic gauze near the base of the thumb at the wrist joint, where the first carpometacarpal joint is located. The spacer is “interpositional,” meaning that it goes between the trapezium bone and the first metacarpal bone.
Artelon CMC Spacer Failures
Artimplant AB and Small Bone Innovations, Inc., claim that the spacer is biocompatible and degradable. They contend that the device offers joint stability, faster recovery, and less pain.
Unfortunately, the manufacturer’s claims have not been born out over the last few years. The FDA has received numerous adverse event reports related to defective Artelon CMC Spacers. Moreover, recent medical studies have shown that the Artelon CMC Spacer is failing at a high rate.
On many occasions, patients have had to undergo painful revision surgeries to have the defective Artelon implant removed. Patients complain of:
If you or a loved one has been injured by a faulty Artelon Spacer, please call attorney Claudine Q. Homolash at (215) 790-7379 for a free consultation.
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The Artelon CMC Spacer
The Artelon CMC Spacer was developed by Artimplant AB and marketed by Small Bone Innovations, Inc. In 2007, the Food and Drug Administration approved the device for use in the United States.
The device was intended to treat early and mid-stage osteoarthritis that occurs in the carpometacarpal thumb joint. Osteoarthritis causes the cartilage to breakdown until the thumb joint can no longer provide cushioning for the bones. The Artelon CMC Spacer is supposed to provide a substitute cushion.
The implant only requires outpatient surgery. Doctors place a T-shaped plastic gauze near the base of the thumb at the wrist joint, where the first carpometacarpal joint is located. The spacer is “interpositional,” meaning that it goes between the trapezium bone and the first metacarpal bone.
Artelon CMC Spacer Failures
Artimplant AB and Small Bone Innovations, Inc., claim that the spacer is biocompatible and degradable. They contend that the device offers joint stability, faster recovery, and less pain.
Unfortunately, the manufacturer’s claims have not been born out over the last few years. The FDA has received numerous adverse event reports related to defective Artelon CMC Spacers. Moreover, recent medical studies have shown that the Artelon CMC Spacer is failing at a high rate.
On many occasions, patients have had to undergo painful revision surgeries to have the defective Artelon implant removed. Patients complain of:
- inflammation
- swelling
- Shooting or burning pain
- Limited range of motion with hand
- Thumb has become misshapen
If you or a loved one has been injured by a faulty Artelon Spacer, please call attorney Claudine Q. Homolash at (215) 790-7379 for a free consultation.
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