This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device disposition is unknown.
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The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6), us.The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 supracondylar nailing system¿ which is associated with the 'stryker t2 supracondylar nailing system'.Within that publication, post-operative complications/ adverse events were reported which occurred between january 2011 to december 2018.It was not possible to ascertain specific device or patient information 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 2 complaint were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses non-union and dynamization.The pmcf states, ¿the patient progressed to a non-union despite physical therapy, high dose vitamin d treatment, use of bone stimulator, and trial of forteo.The non-union was diagnosed approximately ten months postoperatively.The patient subsequently underwent dynamization of the t2 supracondylar nail four months after being diagnosed with the distal femur non-union.This was fourteen months after undergoing removal of hardware and insertion of retrograde intramedullary t2 supracondylar nail.Six months after undergoing nail dynamization, the patient remained symptomatic and the distal femur fracture had not healed.This time period is equivalent to 20 months after undergoing removal of hardware and insertion of retrograde intramedullary t2 supracondylar nail.At this time, the operative surgeon decided to refer the patient to an orthopedic oncologist who specializes in distal femur resection with insertion of mega prosthesis as it was decided this would offer the patient the best chance at returning to performing her daily living activities without any limitation.¿.
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