BACKGROUND: A damaged orthopedic implant in the body can cause problems for the patient and disrupt the therapeutic process. This study investigates various factors for orthopedic implant failures in patients with traumatic lower limb fractures who referred to a trauma center in Mashhad, Iran. METHODS: This was a prospective study of 23 patients referred to Kamyab University Hospital with failed orthopedic implants in 2009. We included any patient with an orthopedic device previously implanted secondary to a traumatic lower limb fracture who later presented to Kamyab University Hospital because of a failed implant. For all patients, a thorough history was taken and the necessary investigations that included radiographic studies were performed. We investigated the quality of the failed devices by chemical analysis, metal hardness testing and metallography. The results were statistically analyzed. RESULTS: The mean age of the patients was 33 ± 19 years. There were 19 (82.5%) male and 4 (17.4%) female patients. In 14 (60.9%) cases, there were failed femoral implants and 9 (39.1%) cases had failed implants for tibial fractures. We compared the implants against ASTM standards. According to chemical analysis, all internally produced devices and one of the leading international brands were within the expected standard. However, in 3 cases chemical analysis showed a deviation from the standards. These were manufactured by "miscellaneous" companies. In one (4.3%) case the device failure was iatrogenic, in 14 (60.9%) it was due to faulty implants and in 8 (34.8%) cases, the patients were non-compliant with instructions. Hardness testing was satisfactory in all cases and metallographic studies showed good quality for the leading international brands, satisfactory quality for the internally produced devices and poor quality for the miscellaneous devices. CONCLUSION: The implants classified as miscellaneous were of poor quality. Thus, we cannot recommend their use in orthopedic surgeries. We recommend using credible, known brands.
BACKGROUND: A damaged orthopedic implant in the body can cause problems for the patient and disrupt the therapeutic process. This study investigates various factors for orthopedic implant failures in patients with traumatic lower limb fractures who referred to a trauma center in Mashhad, Iran. METHODS: This was a prospective study of 23 patients referred to Kamyab University Hospital with failed orthopedic implants in 2009. We included any patient with an orthopedic device previously implanted secondary to a traumatic lower limb fracture who later presented to Kamyab University Hospital because of a failed implant. For all patients, a thorough history was taken and the necessary investigations that included radiographic studies were performed. We investigated the quality of the failed devices by chemical analysis, metal hardness testing and metallography. The results were statistically analyzed. RESULTS: The mean age of the patients was 33 ± 19 years. There were 19 (82.5%) male and 4 (17.4%) female patients. In 14 (60.9%) cases, there were failed femoral implants and 9 (39.1%) cases had failed implants for tibial fractures. We compared the implants against ASTM standards. According to chemical analysis, all internally produced devices and one of the leading international brands were within the expected standard. However, in 3 cases chemical analysis showed a deviation from the standards. These were manufactured by "miscellaneous" companies. In one (4.3%) case the device failure was iatrogenic, in 14 (60.9%) it was due to faulty implants and in 8 (34.8%) cases, the patients were non-compliant with instructions. Hardness testing was satisfactory in all cases and metallographic studies showed good quality for the leading international brands, satisfactory quality for the internally produced devices and poor quality for the miscellaneous devices. CONCLUSION: The implants classified as miscellaneous were of poor quality. Thus, we cannot recommend their use in orthopedic surgeries. We recommend using credible, known brands.