It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient underwent a revision procedure on (b)(6) 2014, due to malpositioning of the femoral and tibial components resulting in loosening of the tibial tray.All components were removed and patient was converted to a total knee during the revision procedure.
|
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 warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-05503 & 05504).
|