Information was received based on review of a journal article entitled, "revision of oxford medial unicompartmental knee arthroplasty to total knee arthroplasty ¿ results of a multicentre study", saldanha, k.Et al.The knee (2007) 275-279.It was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date due to loosening of the femoral component.
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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: date of event - unknown, expiration date - unknown, date implanted - unknown, date explanted - unknown, initial reporter - the article was written by k.A.N.Saldanha et al.In the knee 14 (2007) 275¿279; manufacture date ¿ unknown.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 1825034-2015-03078 which referenced a journal article written on a study that this patient took part in.
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