Batch review performed on 17 may 2018; lot 142826: (b)(4) items manufactured and released on 02 october 2014.Expiration date: 2019-08-31; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs on 17 may 2018; screw refixation surgery is required 2,5 years after primary tka.Radiographic images show the presence of a loose insert fixation screw.This event may be due to insufficient tightening torque but the real cause can't be determined.Immediate repositioning of a new screw is strongly recommended.
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