📊 Evidence-Based Reference
Durom Hip Resurfacing System Femoral Components
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in hip resurfacing arthroplasty for patients with painful and disabling hip disease.
- Intended for patients who have adequate bone stock to support the femoral component.
- Used with the compatible Durom acetabular component as part of the Durom Hip Resurfacing System.
Clinical Applications
- Femoral-side resurfacing during hip resurfacing arthroplasty.
- Treatment of selected patients with degenerative hip disease causing pain and functional limitation.
- Treatment of selected patients with other painful, disabling conditions of the hip when femoral bone quality and anatomy are suitable for resurfacing.
- Use as part of a metal-on-metal hip resurfacing system rather than as a standalone total hip replacement component.
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.
Practical Considerations
- The component must be matched to the compatible acetabular component and selected according to the patient's femoral head and neck anatomy.
- Hip resurfacing requires adequate femoral bone stock; severe bone loss, poor bone quality, or certain femoral head and neck abnormalities may make resurfacing unsuitable.
- Metal-on-metal implants can release metal wear debris. Patient selection, implant positioning, symptoms, and follow-up are important considerations.
- MRI safety and scan conditions depend on the complete implanted system and the specific device labeling. The implant should be identified before MRI, and the current manufacturer conditions should be followed.
- The device is implanted during orthopedic surgery, typically through an open hip approach under general or regional anesthesia; it is not an endovascular or percutaneous 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.