This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a pmcf report from (b)(6) medical center, (b)(6).The title of this report is ¿incidence of avascular necrosis of the femoral head after intramedullary nailing of femoral shaft fractures¿ which is associated with the stryker intramedullary nailing system.Within that publication, post-operative complications/ adverse events were reported which occurred from january 2010 to june 2014.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 5 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses avascular necrosis of the femoral head (avnfh).The study reports, the overall incidence of avnfh after antegrade im nailing of femoral shaft fractures was 0.2% (1 of 542 patients): the patient was a (b)(6)-year-old boy.A (b)(6)-year-old boy with an isolated closed fracture of the right femoral shaft was treated by antegrade intramedullary nailing with trochanteric fossa insertion.The 14-month postoperative radiographs showed fracture-healing, and the patient was pain-free.Twenty-one months after the injury, radiographs of the right hip showed early collapse of the femoral head that was consistent with avascular necrosis.
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