Medical Device Failure Analysis, Fracture Evaluation, Prosthesis Failure

Medical Device Failure Analysis | Fracture Evaluation | Prosthesis Failure

Orthopedic Implants Failures Medical Device Failure Analysis, Fracture Evaluation, Prosthesis Failure

Importance of satisfactory function of prosthetics and Orthopedic Implants cannot be emphasized enough. When orthopedic implants failures take place, at the very least they cause immense discomfort to the recipient. In some cases they can initiate a series of life-threatening complications. When analyzing such failures, utmost care is taken to during the entire failure analysis process to ensure reliability. Orthopedic implant failures have been known to arise out of deficient chemistry, over-load, fatigue or surgical errors. ITS personnel have analyzed cases of failure of total hip implant, failure of rods and nails where consequences have been grave. ITS technical reports have been found valuable in finding the cause of failure to avoid future errors and for settling disputes. Our approach for failure analysis may include

  • Chemical analysis of the material of construction orthopedic implants
  • Study of component history of orthopedic implants
  • Visual examination/fractography
  • Microscopic examination of material samples
  • Micro hardness Dimensional measurements
  • Scanning Electron Microscopy (SEM) and Energy Dispersive X-Ray Spectrometry (EDS)

Based on all observations and analysis, the client is provided with the detailed report that is conclusive, accurate and well illustrated for technical and non technical readers.


Medical Device Failure Analysis, Fracture Evaluation, Prosthesis Failure

A total hip implant (THI) that failed because of manufacturing deficiencies


Medical Device Failure Analysis, Fracture Evaluation, Prosthesis Failure

Cross section of a cast Cobalt-Chromium-Molybdenum implant at 7X magnification.
The large grain size was considered a major weakness in the structure.