The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date explanted - (b)(6) 2007 event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred. should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 11 states, "wear and/or deformation of articulating surfaces.".
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