Information was received based on review of a journal article titled, "the oxford phase iii unicompartmental knee replacement in patients less than 60 years of age", kort, nanne, et al.Knee surg sports traumatol arthrosc (2007) 15:356-360 it was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date due to malalignment.All components were removed and replaced with a total knee.
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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.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 1825034-2015-03183 which referenced a journal article written on a study that this patient took part in.
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