đź“Š Evidence-Based Reference
depuy asr resurfacing femoral heads
Depuy Orthopaedics
Summary: The Depuy ASR Resurfacing Femoral Heads are metal-on-metal hip implants primarily used for hip resurfacing in younger, active patients. Key evidence highlights concerns over wear and adverse tissue reactions.
FDA Clearance Information
Pathway
510K
Number
K032659 ↗
Decision Date
December 4, 2003
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Depuy ASR Resurfacing Femoral Heads were cleared by the FDA via the 510(k) pathway on December 4, 2003. Manufactured by Depuy Orthopaedics, it is classified as a Class 2 device.
What It Is
The Depuy ASR Resurfacing Femoral Heads are metal-on-metal hip implants designed for hip resurfacing procedures. They are intended to preserve more of the patient's natural bone compared to total hip replacement, particularly in younger, active patients.
Clinical Applications
Commonly used in hip resurfacing procedures, these devices are typically indicated for patients with hip joint damage due to osteoarthritis or other degenerative conditions, where bone preservation is a priority.
Evidence Summary
The available literature includes seven studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2011 and 2020. These studies focus on wear, revision rates, and tissue reactions.
Reported Outcomes
Published studies report a wide range of wear and surface features in the Depuy ASR Resurfacing Femoral Heads. Some studies noted high revision rates and adverse tissue reactions, such as metallosis and pseudotumors, particularly when compared to other metal-on-metal hip implants.
Safety Profile
Reported complications include adverse reactions to metal debris (ARMD), metallosis, inflammation, pseudotumors, and necrosis. These complications have been linked to excessive wear and design features of the implant.
Evidence Limitations
The evidence is limited by inconsistent findings regarding the correlation between implant wear and histopathological outcomes. Further research is needed to better understand the long-term performance and safety of these devices.
Frequently Asked Questions
What are the clinical indications for Depuy ASR Resurfacing Femoral Heads?
Indicated for hip resurfacing in patients with joint damage due to osteoarthritis or other degenerative conditions, where bone preservation is desired.
What outcomes have been reported in clinical studies?
Studies report a range of wear and revision rates, with some noting adverse tissue reactions such as metallosis and pseudotumors.
What complications have been reported?
Safety data indicates complications such as adverse reactions to metal debris, metallosis, inflammation, pseudotumors, and necrosis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.