Information was received based on review of a journal article titled, "polyethylene wear in oxford unicompartmental knee replacement: a retrieval study of 47 bearings" kendrick bj et al.In j bone joint surg br.2010 mar;92(3):367-73.Doi: 10.1302/0301-620x.92b3.22491.It was reported that patient underwent a partial knee arthroplasty on an unknown date on an unknown side.Subsequently, patient was revised on an unknown date due to femoral component loosening 6.4 years following the initial procedure.
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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 1825034-2015-03307 which referenced a journal article written on a study that this patient took part in.
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