An FDA orthopedic devices advisory panel unanimously recommended the approval of Johnson & Johnson’s ceramic-on-metal hip bearing implant. In a 5-0 vote, the panel suggested approval of the Pinnacle CoMplete Acetabular Hip System, with conditions that include a 10-year follow up study.
The panel made its recommendation after reviewing a two-year study that compared the Pinnacle’s safety and effectiveness with another DePuy metal-on-metal implant. The study revealed no significant difference between adverse events, revision rates, or survivorship after two years. Patients experienced the same pain relief, range of motion, and improved function as well.
If approved, the device would be intended for patients who experience severe pain and disability as a result of osteoarthritis or post-traumatic arthritis. It would also be the first implant to use ceramic-on-metal instead of metal-on-metal, which is supposed to reduce device wear and be a better alternative for active patients. Lab testing found a greater than 90% reduction in wear versus the metal-on-metal implant under normal gait conditions. It revealed a more than 80% wear reduction under adverse conditions.
