Abstract
Background
The worldwide withdrawal of the DePuy Articular Surface Replacement (ASR) device in both its resurfacing and total hip replacement (THR) form on 26 August 2010, after 93,000 were implanted worldwide, has had major implications. The 2010 National Joint Registry for England and Wales quoted figures of 12-13% failure at five years; however these figures may be an underestimate.
Patients and methods
In 2004 a single surgeon prospective study of the ASR bearing surface was undertaken. Presented are the Adverse Reaction to Metal Debris (ARMD) failure rates of the ASR resurfacing and ASR THR systems. The diagnosis of ARMD was made by the senior author and was based on clinical history, examination, ultrasound findings, metal ion analysis of blood and joint fluid, operative findings and histopathological analysis of tissues retrieved at revision. Acetabular cup position in vivo was determined using EBRA software. Mean follow up was 52 months (24-81) and 70 patients were beyond 6 years of the procedure at the time of writing. Kaplan Meier survival analysis was carried out firstly with joints designated ‘failure’ if the patient had undergone revision surgery or if the patient had been listed for revision. A second survival analysis was carried out with a failure defined as a serum cobalt concentration > 7microgrammes/L (MHRA guideline from MDA-2010-069). Full explant analysis was carried out for retrieved prostheses.
Results
There were 505 ASR hips in total (418 resurfacings and 87 THRs). 657 metal ion samples were available at the time of writing including 152 repeats. Survival analysis using revision/listed for revision as end point (at 6 years): ASR resurfacing: 26.1% failure; ASR THR: 55.5% failure. Survival using ion analysis (at 5 years): ASR resurfacing: 50.1% failure; ASR THR: 66.5% failure. The median (range) volumetric wear rate of failed prostheses was 8.23mm3/year (0.51-95.5). Failure and high ion concentrations are linked to acetabular cup size, anteversion and inclination. Increased failure rates in THRs were due to wear at the taper junction of head and stem.
Conclusion
Design flaws in the ASR have led to excessive wear and consequently catastrophic failure rates secondary to ARMD.
