Information was received based on review of a journal article titled, "the oxford unicompartmental knee prosthesis: an independent 10-year survival analysis" vorlat, p.Et al.Knee surg sports traumatol arthrosc (2006) 14: 40-45 doi: 10.1007/s00167-005-0621-1 it was reported that patient underwent a partial knee arthroplasty on an unknown side on an unknown date.Subsequently, patient was revised due to instability 16 months following the initial procedure.All components were removed and replaced with a total knee system.
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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 article was written by vorlat p, et al in knee surg sports traumatol arthrosc.2006 jan;14(1):40-5.It is likely that these complications and revisions 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.This information was originally reported on 1825034-2015-03285 which referenced a journal article written on a study that this patient took part in.
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