Information was received based on review of a journal article titled, "the management of pediatric subtrochanteric femur fractures with a statically locked intramedullary nail" which aimed to evaluate locked intramedullary fixation as an alternative treatment method for children with subtrochanteric fractures using the statically locked lateral entry intramedullary nail (pediatric locked nail) manufactured at biomet warsaw.The study consisted of 9 males and 1 female patient with an average age of 12 years and average follow-up of 22 months.Most of the fractures occurred secondary to high-energy trauma.Implants were removed on average of 11 months post implantation.There were no intraoperative complications recorded nor major complications in the postoperative period after removal.Two patients presented with a longer limb on the affected side, and two presented with asymptomatic grade i heterotopic ossification.All of which did not require treatment and were linked to the initial trauma, and not the implant.In conclusion, the use of the statically locked laterally entry im nail for subtrochanteric femur fractures in children is a safe and efficacious method of treatment with few complications and risks, and satisfactory outcomes in children over the age of eight.
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Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.Initial reporter -the article was written by herrera-soto, j.Et al; journal of orthopaedic trauma publish ahead of print: doi: 10.1097/bot.0000000000000156.Manufacture date ¿ unknown.It is likely that these complications have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.
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