Initial American experience with hip resurfacing following FDA approval.

UNLABELLED: In May 2006, the US Food and Drug Administration approved the first metal-on-metal total hip resurfacing. Surgeons wanting to implant this device were required to undergo formal industry-sponsored training before performing their first case and a technical specialist attended their initial 10 cases. Safety surveys were completed on the first 537 cases performed and included patient age, gender, diagnosis, and occurrence of any unexpected events perioperatively or postoperatively. Intraoperative data were available for all 537 cases (100%), hospital discharge and six-week data were available for 524 cases (97.6%), three-month data were available for 523 cases (97.4%), six-month data were available for 509 cases (94.3%) and one-year data were available for 449 cases (83.6%); the mean followup was 10.4 months. We documented adverse events in 40 (32 major, 8 minor) of the 537 cases including nine nerve injuries and eight dislocations. There were 14 component revisions (3.1%) [corrected] within the first year, including 10 for femoral neck fracture, two for dislocations, and two for acetabular component loosening. Complications were frequently seen among patients older than 55 years of age and in women, emphasizing the importance of appropriate patient selection for the procedure. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.