The manufacturer became aware of a literature published by the ¿professor of experimental rheumatology, rheumatology and clinical immunology, umc utrecht, netherlands ¿.The title of this report is ¿knee joint distraction compared with total knee arthroplasty: a randomised controlled trial ¿, published on january 1, 2017, which is associated with the stryker ¿monotube triax external fixation system¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/28053257.This report includes an analysis of the clinical data that was collected on 60 patients.The study was conducted between 2011 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available; however, it was reported that 1 patient experienced admission to the hospital shortly after removal of the frame for itnravenous antibiotics, due to staphyloccus aureus sepsis diagnosed from blood culture.There were possibly 8 pins involved.
|
This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿professor of experimental rheumatology, rheumatology and clinical immunology, umc utrecht, netherlands¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/28053257. the reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author. more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
|