The manufacturer became aware of a pmcf final study report that was conducted by university of louisville in the usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (pf) of the t2 alpha femur antegrade gt/pf nailing, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system.This report includes analysis of the clinical data that was collected on 28 patients, the cases in this study range from march 2019 through august 2020.During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available.It was reported that one patient experienced gt bursitis and was referred for physical therapy.The report states: ¿patient k: the following patient had gt bursitis: patient was (b)(6)female, bmi 29.9, nonsmoker, with long term use of bisphosphonates, and history of dementia.Her injury was due to falling from standing and was classified as closed 32-a2 fracture.The devise used for the initial fixation surgery was 10*400 t2 alpha femoral nail pf left, with recon locking mode.The gt bursitis was diagnosed 98 days post-op along with interval bone healing, patient was able to weight bearing as tolerated (wbat) and was referred for physical therapy then lost follow up.¿.
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This complaint has been generated based on findings discovered during post market surveillance pmcf study review.The alleged gt bursitis and was referred for physical therapy included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition is unknown.
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