Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 13 states, "dislocation and subluxation due to inadequate fixation and improper positioning." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02980 / 03976).
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It was reported that patient underwent an initial left partial knee arthroplasty on (b)(6), 2015.Subsequently, patient was revised on (b)(6), 2015 due to a dislocated tibial bearing.The tibial bearing was removed and replaced.Patient was revised again on (b)(6), 2015 due to dislocation.All components were removed and replaced.
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