title: Ceramic total hip arthroplasty in the United States: safety and risk issues revisited.
abstract: 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.
authors.affiliation: Department of Orthopaedic Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Tateiwa
authors.forename: Ian C
authors.initials: IC
authors.lastname: Clarke
authors.forename: Paul A
authors.initials: PA
authors.lastname: Williams
authors.forename: Jonathan
authors.initials: J
authors.lastname: Garino
authors.forename: Masakazu
authors.initials: M
authors.lastname: Manaka
authors.forename: Takaaki
authors.initials: T
authors.lastname: Shishido
authors.forename: Kengo
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Atsuhiro
authors.initials: A
authors.lastname: Imakiire
mesh_terms: D000537:Aluminum Oxide; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000295:instrumentation*; D002516:Ceramics; D004869:Equipment Safety; D006622:Hip Prosthesis / Q000009:adverse effects*; D006801:Humans; D010014:Osteolysis / Q000209:etiology; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D011475:Prosthesis Failure; D014481:United States
chemical_list: D000537:Aluminum Oxide