A voluntary medwatch was received by gore (mw5080790) which reported the following: wl gore soft tissue device for acl substitution, made of polytetrafluoroethylene.I rejected it.The distal aspect of this device disintegrated in vivo.Emergency room visit revealed "(b)(6)" colored fluid tapped from a grossly swollen joint and painful knee joint.Removal of this device was immediately scheduled.Over the years, i became increasingly ill.I am now disabled by illness and intractable pain.Hx: in the late 70s, resorbable screws were used as fixation devices during a routine acl repair.This was my first rejection of an artificial material.After having the wl gore device removed, i underwent an unsuccessful patellar graft, right to left.This failed due to the knee remaining reactive and otherwise problematic.The gore-tex device was placed in the late 80s, rejected in 1994.Ultimately my tkr (1997, johnson & johnson) has now become an object of issue.For the last 4 yrs, the affected joint has become more and more problematic.Currently ,the working diagnosis is that i am rejecting this medical device as well.The reports states implant date: (b)(6) 1989 and explant date: (b)(6) 1994.
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