Information was received based on review of a journal article titled, "perceptions of outcomes after unicompartmental and total knee replacements" weale, a.E., et al.Clinical orthopaedics and related research, number 382, p.143-153 it was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to femoral loosening; however, no revision procedure has been reported to date.
|
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 weale ae et al.In clin orthop relat res.2001 jan;(382):143-53.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 1825034-2015-03249 which referenced a journal article written on a study that this patient took part in.
|