This user facility is outside of the united states.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.Examination of returned device found no evidence of product non-conformance.Root cause of the event was most likely attributed to third party debris, patient anatomy or surgical technique; however, a conclusive determination could not be made.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 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." number 11 states, "wear and/or deformation of articulating surfaces." number 21 states, "non-malignant, non-infective soft tissue masses, sometimes referred to as pseudotumors." under warnings and precautions, number 3 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." number 4 states, "malalignment of components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure." number 5 states, "complete preclosure cleaning and removal of bone cement debris, metallic debris and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces." this report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2015-00286 & 04149).
|