Exactech Recalls 147,000 Knee and Ankle Replacements for Fail Risk

Exactech has issued a product defect recall for about 147,000 knee and ankle replacements sold in the United States since 2004 because they can wear out and fail. According to the company’s website, they are recalling plastic inserts used in knee and ankle replacements because the plastic can deteriorate early and lead to failure of the implant, forcing patients to get corrective surgery.

Knee and Ankle Replacements Could Fail

Patients with deteriorating knee and ankle replacements may require surgery if they experience symptoms such as new or worsening pain, inability to bear weight on the knee or ankle, grinding sounds or noises, swelling, or joint instability. The recall involves plastic inserts known as Exactech Ultra-High Molecular Weight Polyethylene Knee and Ankle Inserts. These are made to fit between the metal parts of a knee or ankle replacement to cushion the joint. Exactech said it recalled the plastic inserts because they were packaged in an “out-of-specification” vacuum-sealed bag that did not prevent oxygen from coming in contact with the insert. Exposure to oxygen could cause the plastic insert to degrade more quickly, leading to early device failure. Exactech further explained that over a period of time, oxidation could cause the mechanical properties of the implant to degrade severely. This could cause “accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture,” all of which could lead to earlier-than-expected revision surgery. The recall covers about 147,732 knee and ankle replacements implanted in the United States since 2004. Exactech has said the recall covers all plastic inserts packaged in “out-of-specification” bags irrespective of label or shelf life.

Responsibility of Medical Device Manufacturers

Medical device manufacturers are responsible for ensuring that their devices, such as implants, are carefully designed, produced, and tested before being made available to the consumer. If there is an issue, side effect, or risk associated with using the product, the medical device manufacturer is legally required to disclose the problems and risks associated with their products. This allows a patient who may be evaluating such a medical device with their healthcare provider to make a better-informed decision. If you have received these or other implants and are forced to undergo earlier-than-expected corrective surgery, you may be able to file a product liability lawsuit against the manufacturer seeking compensation for damages such as medical expenses, lost income, cost of surgery, hospitalization, rehabilitation, permanent injuries, disabilities, and past and future pain and suffering. An experienced product defect lawyer will advise you regarding your legal rights and options.   Source: https://www.exac.com/medical-professionals/recall-information/