Information was received based on review of a journal article titled, "unicompartmental or total knee arthroplasty?" amin, a.Et al.Clinical orthopaedics and related research, no.451, pp.101-106 it was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date 17 months following the initial procedure due to pain.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 following sections could not be completed with the limited information provided.The article was written by amin ak, et al in clin orthop relat res.2006 oct;451:101-6.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 1825034-2015-03253 which referenced a journal article written on a study that this patient took part in.- attachment: [amin 2006-uka or tka.Pdf].
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