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 (b)(4) 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 1991.Subsequently, patient was revised due to loosening on an unknown date six months following the initial procedure.The femoral component was removed and replaced.
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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)(4).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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