Information was received based on review of a journal article entitled, "oxford meniscal bearing knee versus the marmor knee in unicompartmental arthroplasty for arthrosis.A swedish multicenter survival study" lewold, s.Et al.The journal of arthroplasty vol.10 no.6 1995.It was reported that patient underwent a partial knee arthroplasty on an unknown date in 1988.Subsequently, patient was revised due to malpositioning on an unknown date eleven 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 lewold, s.Et al.In the journal of arthroplasty vol.10 no.6 1995.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 1825034-2015-03451 which referenced a journal article written on a study that this patient took part in.
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