Ceramic Total Hip Arthroplasty in the United States: Safety and Risk Issues Revisited
Toshiyuki Tateiwa, MD, Ian C. Clarke, PhD, Paul A. Williams, MSc, Jonathan Garino, MD, Masakazu Manaka, MD, Takaaki Shishido, MD, Kengo Yamamoto, MD, PhD, and Atsuhiro Imakiire, MD, PhD
Dr. Tateiwa is Assistant Professor, Department of Orthopaedic Surgery, Tokyo Medical University, Tokyo, Japan.
Dr. Clarke is Director of Peterson Research Center, and Mr. Williams is Research Instructor, Peterson Tribology Laboratory, Orthopaedic Research Center, Department of Orthopaedic Surgery, Loma Linda University Medical Center, Loma Linda, California.
Dr. Garino is Associate Professor, Department of Orthopaedics, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania.
Dr. Manaka is Assistant Professor, Dr. Shishido is Assistant Professor, Dr. Yamamoto is Professor and Chief, and Dr. Imakiire is Former Professor and Chief, Department of Orthopaedic Surgery, Tokyo Medical University, Tokyo, Japan.
The advantages of all-alumina bearings are superb wear resistance, stability, and inertness demonstrated over 3 decades. The disadvantage is a small risk for brittle
fracture, as described in this paper. Surveying the latest ceramic hip series reported in recent journal articles or presented at the 6th World Biomaterials Congress, we found 11 studies representing more than 35,000 cases followed
for 3 to 25 years. There were 24 reported fractures. A unique survey of hip complications in the 1990s found a fracture risk of approximately 1.4 per 1000 ceramic balls used in the United States. A company database holding more than 2.5 million records described the overall fracture risk as 1 per 10,000 cases. Initial use of ceramic cup inserts indicated a 2% to 3% incidence of chipping during
surgery. Beginning in 1997, the number of ceramic–metal cup-locking cases entered into a US Food and Drug Administration ceramics database was more than 2400, with no fractures reported by the FDA in July 2003.