Dr (b)(6) from the hospital (b)(6) reported to (b)(6), regional director trauma and extremities, the following event: he had encountered a phenomenon of "geode" and "bone lysis" in the radius with the remotion wrist prosthesis.He does not wish to do any immediate material vigilance or to forward us any further information on his specific cases.He informed us that an article on the subject will be published in the december issue of the scientific journal "maitrise orthopédique" on his case series.Unfortunately, we were unable to obtain any further information.No more information for now; as soon as (b)(6) receives the december review, he will send it to ra/qa team the article in question and the pi will be completed in accordance to the article.Additional information from received article: the manufacturer became aware of a study from (b)(6).The title of this study is (b)(6) and is associated with the remotion total wrist system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015.It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lyses.22 out of 22 cases.
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