Information was received based on review of a journal article titled, "oxford medial unicompartmental knee arthroplasty in patients younger and older than 60 years of age", price, aj, et al.British editorial society of bone and joint surgery (2005) doi: 10.1302/0301-620x.87b11.16324.It was reported that patient underwent a partial knee arthroplasty on an unknown date.Subsequently, patient was revised due to femoral component loosening 1.6 years 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.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.(b)(6).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 1825034-2015-03144 which referenced a journal article written on a study that this patient took part in.
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