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durom hip resurfacing system femoral components
Zimmer
Summary: The Durom Hip Resurfacing System by Zimmer is a metal-on-metal hip implant cleared by the FDA for hip resurfacing procedures. Key evidence highlights include long-term survival rates and factors predictive of failure.
FDA Clearance Information
Pathway
510K
Number
K070292 ↗
Decision Date
April 26, 2007
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Durom Hip Resurfacing System was cleared by the FDA via the 510(k) pathway on April 26, 2007. It is manufactured by Zimmer and classified as a Class 2 device.
What It Is
The Durom Hip Resurfacing System is a metal-on-metal hip implant designed for hip resurfacing procedures. It is intended to preserve more bone compared to traditional hip replacements, making it suitable for younger, active patients.
Clinical Applications
This device is commonly used in patients with degenerative hip disorders who are younger and more active, as it allows for bone preservation and potentially better functional outcomes compared to total hip arthroplasty.
Evidence Summary
The available literature includes 12 studies, comprising retrospective analyses and case series, with publication dates ranging from 2012 to 2025. These studies evaluate the device's long-term survival, functional outcomes, and factors influencing failure.
Reported Outcomes
Published studies report that the Durom Hip Resurfacing System has shown good functional outcomes in selected patients, with improved survival rates noted after 10 years. However, some studies highlight the importance of surgical experience in achieving optimal component positioning and reducing failure rates.
Safety Profile
Reported complications include adverse reactions to metal debris (ARMD) and elevated blood metal ion levels, which have been associated with early failure in some cases. Regular monitoring of metal ion levels is recommended to mitigate these risks.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the variability in patient selection criteria. Further research is needed to better understand the long-term safety profile and to identify patient populations that may benefit most from this device.
Frequently Asked Questions
What are the clinical indications for Durom Hip Resurfacing System?
The device is indicated for hip resurfacing in patients with degenerative hip disorders, particularly younger, active individuals who may benefit from bone preservation.
What outcomes have been reported in clinical studies?
Studies have reported good functional outcomes and improved survival rates in selected patients, with surgical experience playing a key role in success.
What complications have been reported?
Safety data indicate complications such as adverse reactions to metal debris and elevated metal ion levels, which can lead to early failure.
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.