What does research say about Exactech implants and revision?
FDA says many Exactech knee, ankle and hip parts were packed in bags that were missing one of the layers that keep out oxygen. It says some recalled devices are linked to a higher risk of a second surgery and bone loss from wear. That is not a finding about any one person’s joint.
FDA’s recall records say the knee inserts were packed in vacuum bags that lacked an extra oxygen barrier layer. The records also list Vantage ankle liners.
If you have an Exactech ankle: MedlinePlus lists loosening over time as a risk of any ankle replacement. When the federal cases were grouped in 2022, none were about the Vantage ankle. Ask your foot and ankle surgeon what your scans show.
A Hospital for Special Surgery study looked at 7,941 Optetrak knees. In 209 of 369 revisions, surgeons found worn plastic, bone loss and loose parts. These failures came about five years after the first surgery, on average.
A Nashville clinic found that 17 of 896 Optetrak Logic and Truliant knees were redone because the thigh-bone part came loose. More than half of these patients had plain X-rays that did not show it.
Studies like these describe groups of patients. They cannot show why one person’s implant failed. In the federal court records we read, we found no ruling on whether the packaging caused anyone’s harm.