Martin, j.G.Et al.The knee.Vol.2, no.2, pp.121-125, 1995.Information was received based on review of a journal article entitled, "revision of unicondylar knee replacements to total knee replacement." it was reported that patient underwent an initial partial knee arthroplasty on an unknown date.Subsequently, patient was revised due to loosening on an unknown date after a 49 month follow-up.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.(b)(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 1825034-2015-03122 which referenced a journal article written on a study that this patient took part in.
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