Implant Failure: STRATOS System for Pectus Repair.
Prashant K Sharma1, Tineke P Willems2, Daan J Touw3
1Department of Biomedical Engineering, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
The Annals of Thoracic Surgery
|October 22, 2016
Summary
Failures of the STRATOS titanium pectus repair system were investigated. The study found that mechanical loading caused implant fractures and loosening, releasing titanium debris and necessitating implant removal.
Area of Science:
- Biomaterials science
- Orthopedic surgery
- Failure analysis
Background:
- The STRATOS titanium system for pectus repair, approved since 2007, has experienced reported failures.
- Causes of these dramatic failures have not been thoroughly investigated.
Purpose of the Study:
- To investigate the causes of STRATOS titanium system failures in pectus repair patients.
- To analyze explanted implants and surrounding tissue for evidence of material degradation and wear.
Main Methods:
- Surgical explantation of 12 failed STRATOS implants and surrounding tissue biopsies.
- Failure analysis using scanning electron microscopy and energy dispersive X-ray spectroscopy.
- Histologic examination for titanium wear debris and metallosis.
Main Results:
- All explanted implants showed fractures or loosened crimp connectors.
- Fracture surfaces lacked signs of plastic deformation, indicating fatigue.
- Biopsies revealed significant amounts of titanium debris (0.4-105 mg/g) in surrounding tissues, consistent with metallosis.
Conclusions:
- Mechanical loading during respiration caused implant loosening and fatigue fractures.
- Titanium release may lead to metallosis, posing risks to vital organs.
- Close patient monitoring and STRATOS implant removal are recommended; clinical use requires reconsideration.
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